DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 1

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** 3 **
3D IMAGING DRUG
* 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
3M
* 3M CO
PERIDEX, CHLORHEXIDINE GLUCONATE
* 3M HEALTH CARE INC
AVAGARD, ALCOHOL (OTC)
DURAPREP, IODINE POVACRYLEX (OTC)
3M DRUG DELIVERY
* 3M DRUG DELIVERY SYSTEMS
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
PROVENTIL-HFA, ALBUTEROL SULFATE
3M HEALTH CARE
* 3M HEALTH CARE INFECTION PREVENTION DIV
SOLUPREP, CHLORHEXIDINE GLUCONATE (OTC)
** 6 **
60 DEGREES PHARMS
* 60 DEGREES PHARMACEUTICALS LLC
ARAKODA, TAFENOQUINE SUCCINATE
** A **
AAA USA INC
* ADVANCED ACCELERATOR APPLICATIONS USA INC
LUTATHERA, LUTETIUM DOTATATE LU-177
NETSPOT, GALLIUM DOTATATE GA-68
AAIPHARMA LLC
* AAIPHARMA LLC
AZASAN, AZATHIOPRINE
ABBVIE
* ABBVIE INC
ANDROGEL, TESTOSTERONE
CREON, PANCRELIPASE (AMYLASE
CYCLOSPORINE, CYCLOSPORINE
DEPAKOTE ER, DIVALPROEX SODIUM
DEPAKOTE, DIVALPROEX SODIUM
GENGRAF, CYCLOSPORINE
K-TAB, POTASSIUM CHLORIDE
KALETRA, LOPINAVIR
MARINOL, DRONABINOL
NIASPAN, NIACIN
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMBEX, CISATRACURIUM BESYLATE
NORVIR, RITONAVIR
SURVANTA, BERACTANT
SYNTHROID, LEVOTHYROXINE SODIUM **
TARKA, TRANDOLAPRIL
TRICOR, FENOFIBRATE
TRILIPIX, CHOLINE FENOFIBRATE
ULTANE, SEVOFLURANE
ZEMPLAR, PARICALCITOL
ABBVIE ENDOCRINE
* ABBVIE ENDOCRINE INC
LUPANETA PACK, LEUPROLIDE ACETATE
ABBVIE ENDOCRINE INC
* ABBVIE ENDOCRINE INC
LUPRON DEPOT, LEUPROLIDE ACETATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 2

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ABBVIE ENDOCRINE INC
LUPRON DEPOT-PED, LEUPROLIDE ACETATE
ABBVIE INC
* ABBVIE INC
DUOPA, CARBIDOPA
MAVYRET, GLECAPREVIR
NORVIR, RITONAVIR
ORILISSA, ELAGOLIX SODIUM
RINVOQ, UPADACITINIB
VENCLEXTA, VENETOCLAX
VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM
ABHAI INC
* ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
ABHAI LLC
* ABHAI LLC
ATOVAQUONE, ATOVAQUONE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
LEFLUNOMIDE, LEFLUNOMIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
URSODIOL, URSODIOL
ABON PHARMS LLC
* ABON PHARMACEUTICALS LLC
CLOFARABINE, CLOFARABINE
ABRAXIS BIOSCIENCE
* ABRAXIS BIOSCIENCE LLC
ABRAXANE, PACLITAXEL
ABRAXIS PHARM
* ABRAXIS PHARMACEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
ACADIA PHARMS INC
* ACADIA PHARMACEUTICALS INC
NUPLAZID, PIMAVANSERIN TARTRATE
ACCELRX LABS
* ACCELRX LABS LLC
CARISOPRODOL, CARISOPRODOL
ACCORD HLTHCARE
* ACCORD HEALTHCARE INC
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ARIPIPRAZOLE, ARIPIPRAZOLE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AZACITIDINE, AZACITIDINE
BICALUTAMIDE, BICALUTAMIDE
BIVALIRUDIN, BIVALIRUDIN
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CAPECITABINE, CAPECITABINE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARBOPLATIN, CARBOPLATIN
CISPLATIN, CISPLATIN
CLOFARABINE, CLOFARABINE
CLONAZEPAM, CLONAZEPAM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CLOZAPINE, CLOZAPINE
DALFAMPRIDINE, DALFAMPRIDINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 3

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ACCORD HEALTHCARE INC
DAPTOMYCIN, DAPTOMYCIN
DECITABINE, DECITABINE
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DOCETAXEL, DOCETAXEL
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
ENTECAVIR, ENTECAVIR
EPLERENONE, EPLERENONE
EPTIFIBATIDE, EPTIFIBATIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
ETOPOSIDE, ETOPOSIDE
EZETIMIBE, EZETIMIBE
FINASTERIDE, FINASTERIDE
FLUOROURACIL, FLUOROURACIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ITRACONAZOLE, ITRACONAZOLE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL, LISINOPRIL
LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHYLDOPA, METHYLDOPA
MITOMYCIN, MITOMYCIN
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PARICALCITOL, PARICALCITOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PRASUGREL, PRASUGREL HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RAMIPRIL, RAMIPRIL
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
SPIRONOLACTONE, SPIRONOLACTONE
TACROLIMUS, TACROLIMUS
TADALAFIL, TADALAFIL
TEMOZOLOMIDE, TEMOZOLOMIDE
TEMSIROLIMUS, TEMSIROLIMUS
TERIFLUNOMIDE, TERIFLUNOMIDE
TOPIRAMATE, TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ACCORD HLTHCARE INC
* ACCORD HEALTHCARE INC USA
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 4

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ACCORD HEALTHCARE INC USA
BUSULFAN, BUSULFAN
TIGECYCLINE, TIGECYCLINE
ACELLA
* ACELLA PHARMACEUTICALS LLC
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN
CICLOPIROX, CICLOPIROX
PHENYTOIN SODIUM, PHENYTOIN SODIUM
ACELLA PHARMS LLC
* ACELLA PHARMACEUTICALS LLC
GABAPENTIN, GABAPENTIN
ACELRX PHARMS
* ACELRX PHARMACEUTICALS INC
DSUVIA, SUFENTANIL CITRATE
ACERUS
* ACERUS PHARMACEUTICALS CORP
NATESTO, TESTOSTERONE
ACI HEALTHCARE LTD
* ACI HEALTHCARE LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
LEVETIRACETAM, LEVETIRACETAM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ACIC PHARMS
* ACIC PHARMACEUTICALS INC
LEVETIRACETAM, LEVETIRACETAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
ACORDA
* ACORDA THERAPEUTICS INC
AMPYRA, DALFAMPRIDINE
INBRIJA, LEVODOPA
ACP NIMBLE
* ACP NIMBLE BUYER INC
ACEPHEN, ACETAMINOPHEN (OTC)
ACYCLOVIR, ACYCLOVIR
BETA-VAL, BETAMETHASONE VALERATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
DESONIDE, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
DOXYCYCLINE, DOXYCYCLINE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
INDOMETHACIN, INDOMETHACIN
LIDOCAINE, LIDOCAINE
METRONIDAZOLE, METRONIDAZOLE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MYKACET, NYSTATIN
NYSTATIN, NYSTATIN
PROCHLORPERAZINE, PROCHLORPERAZINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
TAZAROTENE, TAZAROTENE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 5

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
ACROTECH
* ACROTECH BIOPHARMA LLC
BELEODAQ, BELINOSTAT
EVOMELA, MELPHALAN HYDROCHLORIDE
FOLOTYN, PRALATREXATE
FUSILEV, LEVOLEUCOVORIN CALCIUM
KHAPZORY, LEVOLEUCOVORIN
MARQIBO KIT, VINCRISTINE SULFATE
ACS DOBFAR
* ACS DOBFAR SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOXITIN, CEFOXITIN SODIUM
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
MEROPENEM, MEROPENEM
ACS DOBFAR SPA
* ACS DOBFAR SPA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
ERTAPENEM SODIUM, ERTAPENEM SODIUM
MEROPENEM, MEROPENEM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
ACTAVIS ELIZABETH
* ACTAVIS ELIZABETH LLC
ALBENDAZOLE, ALBENDAZOLE
ALPRAZOLAM, ALPRAZOLAM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DEFERASIROX, DEFERASIROX
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, DEXTROMETHORPHAN HYDROBROMIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GABAPENTIN, GABAPENTIN
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDAPAMIDE, INDAPAMIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOVASTATIN, LOVASTATIN
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
NIFEDIPINE, NIFEDIPINE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)
OXAZEPAM, OXAZEPAM
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 6

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ACTAVIS ELIZABETH LLC
PROPYLTHIOURACIL, PROPYLTHIOURACIL
RANOLAZINE, RANOLAZINE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TEMAZEPAM, TEMAZEPAM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
ALPRAZOLAM, ALPRAZOLAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
MORPHINE SULFATE, MORPHINE SULFATE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
ACTAVIS INC
* ACTAVIS INC
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
METHOXSALEN, METHOXSALEN
ACTAVIS LABS
* ACTAVIS LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
PERMETHRIN, PERMETHRIN
ACTAVIS LABS FL
* ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)
GUAIFENESIN, GUAIFENESIN (OTC)
MESALAMINE, MESALAMINE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
ACTAVIS LABS FL INC
* ACTAVIS LABORATORIES FL INC
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARTIA XT, DILTIAZEM HYDROCHLORIDE
CLARITHROMYCIN, CLARITHROMYCIN
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DALFAMPRIDINE, DALFAMPRIDINE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE
DUTASTERIDE, DUTASTERIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE (OTC)
METAXALONE, METAXALONE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
NAPROXEN SODIUM, NAPROXEN SODIUM
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NITROGLYCERIN, NITROGLYCERIN
OMEPRAZOLE, OMEPRAZOLE
OXYCODONE AND ASPIRIN, ASPIRIN
PALIPERIDONE, PALIPERIDONE
PAROXETINE MESYLATE, PAROXETINE MESYLATE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISONE, PREDNISONE
RAMELTEON, RAMELTEON
RISPERIDONE, RISPERIDONE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 7

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ACTAVIS LABORATORIES FL INC
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAZTIA XT, DILTIAZEM HYDROCHLORIDE
TETRABENAZINE, TETRABENAZINE
TRANEXAMIC ACID, TRANEXAMIC ACID
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ACTAVIS LABS UT INC
* ACTAVIS LABORATORIES UT INC
AZELAIC ACID, AZELAIC ACID
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLONIDINE, CLONIDINE
FIORICET W/ CODEINE, ACETAMINOPHEN
LIDOCAINE, LIDOCAINE
PROGESTERONE, PROGESTERONE
TESTOSTERONE, TESTOSTERONE
* ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
PIMECROLIMUS, PIMECROLIMUS
TESTOSTERONE, TESTOSTERONE
ACTAVIS LLC
* ACTAVIS LLC
AZACITIDINE, AZACITIDINE
DAPSONE, DAPSONE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
* ACTAVIS LLC AN INDIRECT WHOLLY-OWNED SUB OF TEVA PHARMACEUTICALS USA INC
BUSULFAN, BUSULFAN
DOCETAXEL, DOCETAXEL
HYDROXOCOBALAMIN, HYDROXOCOBALAMIN
OXALIPLATIN, OXALIPLATIN
ACTAVIS MID ATLANTIC
* ACTAVIS MID ATLANTIC LLC
ACYCLOVIR, ACYCLOVIR
ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE
ADAPALENE, ADAPALENE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
DESOXIMETASONE, DESOXIMETASONE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
ENULOSE, LACTULOSE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
HYDROCORTISONE, HYDROCORTISONE
LEVETIRACETAM, LEVETIRACETAM
NITROFURANTOIN, NITROFURANTOIN
NYSTATIN, NYSTATIN
PROMETH VC W/ CODEINE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
VALNAC, BETAMETHASONE VALERATE
* ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
IBUPROFEN, IBUPROFEN
PERMETHRIN, PERMETHRIN (OTC)
ACTAVIS PHARMA
* ACTAVIS PHARMA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
MICONAZOLE NITRATE, MICONAZOLE NITRATE
ACTAVIS TOTOWA
* ACTAVIS TOTOWA LLC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 8

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ACTAVIS TOTOWA LLC
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
REPAGLINIDE, REPAGLINIDE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ACTAVIS TOTOWA TEVA
* ACTAVIS TOTOWA LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
FINASTERIDE, FINASTERIDE
ACTELION PHARMS
* ACTELION PHARMACEUTICALS LTD
TRACLEER, BOSENTAN
ACTELION PHARMS LTD
* ACTELION PHARMACEUTICALS LTD
OPSUMIT, MACITENTAN
TRACLEER, BOSENTAN
UPTRAVI, SELEXIPAG
VELETRI, EPOPROSTENOL SODIUM
VENTAVIS, ILOPROST
ZAVESCA, MIGLUSTAT
ACTIENT PHARMS
* ACTIENT PHARMACEUTICALS LLC
THEO-24, THEOPHYLLINE
ADAMAS PHARMA
* ADAMAS PHARMA LLC
GOCOVRI, AMANTADINE HYDROCHLORIDE
ADAMIS PHARMS CORP
* ADAMIS PHARMACEUTICALS CORP
SYMJEPI, EPINEPHRINE
ADAPT
* ADAPT PHARMA OPERATIONS LTD
NARCAN, NALOXONE HYDROCHLORIDE
ADARE PHARMS INC
* ADARE PHARMACEUTICALS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
ADDMEDICA SAS
* ADDMEDICA SAS
SIKLOS, HYDROXYUREA
ADHERA
* ADHERA THERAPEUTICS INC
PRESTALIA, AMLODIPINE BESYLATE
ADIENNE SA
* ADIENNE SA
TEPADINA, THIOTEPA
AEGERION
* AEGERION PHARMACEUTICALS INC
JUXTAPID, LOMITAPIDE MESYLATE
AERIE PHARMS INC
* AERIE PHARMACEUTICALS INC
RHOPRESSA, NETARSUDIL DIMESYLATE
ROCKLATAN, LATANOPROST
AGIOS PHARMS INC
* AGIOS PHARMACEUTICALS INC
TIBSOVO, IVOSIDENIB
AGNITIO
* AGNITIO INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 9

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AGNITIO INC
ETHACRYNIC ACID, ETHACRYNIC ACID
TRIAMTERENE, TRIAMTERENE
AGOURON PHARMS
* AGOURON PHARMACEUTICALS LLC
VIRACEPT, NELFINAVIR MESYLATE
AILEX PHARMS LLC
* AILEX PHARMACEUTICALS LLC
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, BISMUTH
CROMOLYN SODIUM, CROMOLYN SODIUM
SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE
AJANTA PHARMA LTD
* AJANTA PHARMA LTD
ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE
AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE
ARIPIPRAZOLE, ARIPIPRAZOLE
CAPTOPRIL, CAPTOPRIL
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE
ENTACAPONE, ENTACAPONE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANOLAZINE, RANOLAZINE
RISPERIDONE, RISPERIDONE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SILODOSIN, SILODOSIN
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
TADALAFIL, TADALAFIL
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
ZOLMITRIPTAN, ZOLMITRIPTAN
AKARX INC
* AKARX INC
DOPTELET, AVATROMBOPAG MALEATE
AKCEA THERAPS
* AKCEA THERAPEUTICS INC
TEGSEDI, INOTERSEN SODIUM
AKORN
* AKORN INC
ADENOSINE, ADENOSINE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AK-FLUOR 25%, FLUORESCEIN SODIUM
AKBETA, LEVOBUNOLOL HYDROCHLORIDE
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE
AKTEN, LIDOCAINE HYDROCHLORIDE
AKTOB, TOBRAMYCIN
ALFENTA, ALFENTANIL HYDROCHLORIDE
ATROPINE SULFATE, ATROPINE SULFATE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BACITRACIN, BACITRACIN
BAL, DIMERCAPROL
BALANCED SALT, CALCIUM CHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CALCITRIOL, CALCITRIOL
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CARBOPLATIN, CARBOPLATIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 10

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AKORN INC
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CROMOLYN SODIUM, CROMOLYN SODIUM
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DESOXIMETASONE, DESOXIMETASONE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPTIFIBATIDE, EPTIFIBATIDE
ERYTHROMYCIN, ERYTHROMYCIN
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
GENTAK, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IC-GREEN, INDOCYANINE GREEN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
LATANOPROST, LATANOPROST
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NEDOCROMIL SODIUM, NEDOCROMIL SODIUM
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
OFLOXACIN, OFLOXACIN
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
PARICALCITOL, PARICALCITOL
PYRAZINAMIDE, PYRAZINAMIDE
RIFAMPIN, RIFAMPIN
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TIMOLOL MALEATE, TIMOLOL MALEATE
TIMOLOL, TIMOLOL
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TRANEXAMIC ACID, TRANEXAMIC ACID
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TROPICACYL, TROPICAMIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
AKORN INC
* AKORN INC
ACETYLCYSTEINE, ACETYLCYSTEINE
APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CYCLOPENTOLATE HYDROCHLORIDE, CYCLOPENTOLATE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 11

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AKORN INC
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
DRONABINOL, DRONABINOL
EPHEDRINE SULFATE, EPHEDRINE SULFATE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
INAPSINE, DROPERIDOL
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
TOBRAMYCIN, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ALAN LABS INC
* ALAN LABORATORIES INC
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
ALCON
* ALCON LABORATORIES INC
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE
MIOSTAT, CARBACHOL
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
ALCON LABS
* ALCON LABORATORIES LTD
TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE
ALCON LABS INC
* ALCON LABORATORIES INC
ALCAINE, PROPARACAINE HYDROCHLORIDE
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE
FLUORESCITE, FLUORESCEIN SODIUM
ISOPTO ATROPINE, ATROPINE SULFATE
ALCON PHARMS LTD
* ALCON PHARMACEUTICALS LTD
BETADINE, POVIDONE-IODINE
ZADITOR, KETOTIFEN FUMARATE (OTC)
ALEMBIC LTD
* ALEMBIC LTD
LITHIUM CARBONATE, LITHIUM CARBONATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ALEMBIC PHARMS LTD
* ALEMBIC PHARMACEUTICALS LTD
ACETAZOLAMIDE, ACETAZOLAMIDE
ACYCLOVIR, ACYCLOVIR
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
ARIPIPRAZOLE, ARIPIPRAZOLE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BIMATOPROST, BIMATOPROST
BROMFENAC SODIUM, BROMFENAC SODIUM
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 12

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ALEMBIC PHARMACEUTICALS LTD
CELECOXIB, CELECOXIB
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
DEFERASIROX, DEFERASIROX
DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE
DESVENLAFAXINE, DESVENLAFAXINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
FAMOTIDINE, FAMOTIDINE
FEBUXOSTAT, FEBUXOSTAT
FENOFIBRATE, FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
ITRACONAZOLE, ITRACONAZOLE
LAMOTRIGINE, LAMOTRIGINE
LEFLUNOMIDE, LEFLUNOMIDE
LINEZOLID, LINEZOLID
LITHIUM CARBONATE, LITHIUM CARBONATE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
MEPROBAMATE, MEPROBAMATE
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
MODAFINIL, MODAFINIL
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PREGABALIN, PREGABALIN
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SILODOSIN, SILODOSIN
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
TADALAFIL, TADALAFIL
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TELMISARTAN, TELMISARTAN
TEMAZEPAM, TEMAZEPAM
TERIFLUNOMIDE, TERIFLUNOMIDE
THEOPHYLLINE, THEOPHYLLINE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOBRAMYCIN, TOBRAMYCIN
TRAVOPROST, TRAVOPROST
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSARTAN, VALSARTAN
VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
ALEOR DERMACEUTICALS
* ALEOR DERMACEUTICALS LTD
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 13

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ALEOR DERMACEUTICALS LTD
DESONIDE, DESONIDE
LIDOCAINE, LIDOCAINE
ALEXZA PHARMS
* ALEXZA PHARMACEUTICALS INC
ADASUVE, LOXAPINE
ALFASIGMA
* ALFASIGMA USA INC
ZELNORM, TEGASEROD MALEATE
ALIGNSCIENCE PHARMA
* ALIGNSCIENCE PHARMA INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
ALIMERA SCIENCES INC
* ALIMERA SCIENCES INC
ILUVIEN, FLUOCINOLONE ACETONIDE
ALKALOIDA ZRT
* ALKALOIDA CHEMICAL CO ZRT
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
ALKEM
* ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
GABAPENTIN, GABAPENTIN
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ALKEM LABS LTD
* ALKEM LABORATORIES LTD
AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE
ARIPIPRAZOLE, ARIPIPRAZOLE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
CAPECITABINE, CAPECITABINE
CEFIXIME, CEFIXIME
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE
CLOBAZAM, CLOBAZAM
COLCHICINE, COLCHICINE
COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE
DALFAMPRIDINE, DALFAMPRIDINE
DEFERASIROX, DEFERASIROX
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
EZETIMIBE AND SIMVASTATIN, EZETIMIBE
EZETIMIBE, EZETIMIBE
FINASTERIDE, FINASTERIDE
GABAPENTIN, GABAPENTIN
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
ITRACONAZOLE, ITRACONAZOLE
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
LIDOCAINE, LIDOCAINE
LINEZOLID, LINEZOLID
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
OLANZAPINE, OLANZAPINE
OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PREGABALIN, PREGABALIN
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RASAGILINE MESYLATE, RASAGILINE MESYLATE
RILUZOLE, RILUZOLE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 14

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ALKEM LABORATORIES LTD
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VALSARTAN, VALSARTAN
ALKERMES
* ALKERMES INC
VIVITROL, NALTREXONE
ALKERMES INC
* ALKERMES INC
ARISTADA INITIO KIT, ARIPIPRAZOLE LAUROXIL
ARISTADA, ARIPIPRAZOLE LAUROXIL
ALLEGIANCE HLTHCARE
* ALLEGIANCE HEALTHCARE CORP
POVIDONE IODINE, POVIDONE-IODINE (OTC)
ALLEGIS
* ALLEGIS HOLDINGS LLC
PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE
ALLERGAN
* ALLERGAN
ACULAR LS, KETOROLAC TROMETHAMINE
ALPHAGAN P, BRIMONIDINE TARTRATE
BLEPH-10, SULFACETAMIDE SODIUM
GENOPTIC, GENTAMICIN SULFATE
ZYMAXID, GATIFLOXACIN
* ALLERGAN INC
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACZONE, DAPSONE
ALOCRIL, NEDOCROMIL SODIUM
ALPHAGAN P, BRIMONIDINE TARTRATE
AVAGE, TAZAROTENE
COMBIGAN, BRIMONIDINE TARTRATE
ELESTAT, EPINASTINE HYDROCHLORIDE
LASTACAFT, ALCAFTADINE
LATISSE, BIMATOPROST
LUMIGAN, BIMATOPROST
OCUFLOX, OFLOXACIN
OZURDEX, DEXAMETHASONE
POLYTRIM, POLYMYXIN B SULFATE
RESTASIS MULTIDOSE, CYCLOSPORINE
RESTASIS, CYCLOSPORINE
TAZORAC, TAZAROTENE
ZYMAR, GATIFLOXACIN
* ALLERGAN PHARMACEUTICAL
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE
BLEPHAMIDE, PREDNISOLONE ACETATE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
OCUFEN, FLURBIPROFEN SODIUM
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE
* ALLERGAN SALES LLC
ACTIGALL, URSODIOL
ALORA, ESTRADIOL
ANDRODERM, TESTOSTERONE
AVYCAZ, AVIBACTAM SODIUM
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 15

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ALLERGAN SALES LLC
BREVICON 28-DAY, ETHINYL ESTRADIOL
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
CANASA, MESALAMINE
CARAFATE, SUCRALFATE
CELEXA, CITALOPRAM HYDROBROMIDE
CONDYLOX, PODOFILOX
CRINONE, PROGESTERONE
DALVANCE, DALBAVANCIN HYDROCHLORIDE
ESTRACE, ESTRADIOL
FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
GELNIQUE, OXYBUTYNIN CHLORIDE
INFED, IRON DEXTRAN
KADIAN, MORPHINE SULFATE
LEXAPRO, ESCITALOPRAM OXALATE
LINZESS, LINACLOTIDE
MICROZIDE, HYDROCHLOROTHIAZIDE
NAMENDA, MEMANTINE HYDROCHLORIDE
NAMZARIC, DONEPEZIL HYDROCHLORIDE
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
OXYTROL FOR WOMEN, OXYBUTYNIN (OTC)
OXYTROL, OXYBUTYNIN
PYLERA, BISMUTH SUBCITRATE POTASSIUM
RAPAFLO, SILODOSIN
RECTIV, NITROGLYCERIN
SAPHRIS, ASENAPINE MALEATE
SAVELLA, MILNACIPRAN HYDROCHLORIDE
TEFLARO, CEFTAROLINE FOSAMIL
TRELSTAR, TRIPTORELIN PAMOATE
UBRELVY, UBROGEPANT
URSO 250, URSODIOL
URSO FORTE, URSODIOL
VIIBRYD, VILAZODONE HYDROCHLORIDE
VRAYLAR, CARIPRAZINE HYDROCHLORIDE
ALLERGAN HOLDINGS
* ALLERGAN HOLDINGS UNLTD CO
VIBERZI, ELUXADOLINE
ALLERQUEST
* ALLERQUEST LLC
PRE-PEN, BENZYLPENICILLOYL POLYLYSINE
ALLIED
* ALLIED PHARMA INC
CARISOPRODOL, CARISOPRODOL
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
ALMIRALL
* ALMIRALL LLC
ACTICLATE, DOXYCYCLINE HYCLATE
ACZONE, DAPSONE
ALTABAX, RETAPAMULIN
AZELEX, AZELAIC ACID
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
FLUOROPLEX, FLUOROURACIL
SEYSARA, SARECYCLINE HYDROCHLORIDE
VELTIN, CLINDAMYCIN PHOSPHATE
VERDESO, DESONIDE
XOLEGEL, KETOCONAZOLE
ALNYLAM PHARMS INC
* ALNYLAM PHARMACEUTICALS INC
GIVLAARI, GIVOSIRAN SODIUM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 16

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ALNYLAM PHARMACEUTICALS INC
ONPATTRO, PATISIRAN SODIUM
ALRA
* ALRA LABORATORIES INC
CHOLAC, LACTULOSE
CONSTILAC, LACTULOSE
GEN-XENE, CLORAZEPATE DIPOTASSIUM
IBU-TAB 200, IBUPROFEN (OTC)
IBU-TAB, IBUPROFEN
ALTAIRE PHARMS INC
* ALTAIRE PHARMACEUTICALS INC
ALTAFLUOR BENOX, BENOXINATE HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)
OFLOXACIN, OFLOXACIN
ALTATHERA PHARMS LLC
* ALTATHERA PHARMACEUTICALS LLC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
ALVOGEN
* ALVOGEN GROUP HOLDINGS 2 LLC
DAPSONE, DAPSONE
ETHACRYNIC ACID, ETHACRYNIC ACID
OFLOXACIN, OFLOXACIN
* ALVOGEN GROUP HOLDINGS 3 LLC
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FORFIVO XL, BUPROPION HYDROCHLORIDE
* ALVOGEN GROUP HOLDINGS 4 LLC
THYRO-TABS, LEVOTHYROXINE SODIUM **
* ALVOGEN GROUP HOLDINGS LLC
ADALAT CC, NIFEDIPINE
* ALVOGEN INC
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
* ALVOGEN MALTA OPERATIONS LTD
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
BONSITY, TERIPARATIDE RECOMBINANT HUMAN
BUDESONIDE, BUDESONIDE
CARBIDOPA, CARBIDOPA
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DISULFIRAM, DISULFIRAM
EXEMESTANE, EXEMESTANE
FELBAMATE, FELBAMATE
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
MELPHALAN, MELPHALAN
NAPRELAN, NAPROXEN SODIUM
NATEGLINIDE, NATEGLINIDE
NEVIRAPINE, NEVIRAPINE
NITROGLYCERIN, NITROGLYCERIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RIVASTIGMINE, RIVASTIGMINE
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
SPECTAZOLE, ECONAZOLE NITRATE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
TENORMIN, ATENOLOL
VORICONAZOLE, VORICONAZOLE
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL
ALVOGEN INC
* ALVOGEN INC
ACETYLCYSTEINE, ACETYLCYSTEINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 17

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ALVOGEN INC
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE
ALVOGEN PINE BROOK
* ALVOGEN PINE BROOK LLC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
ESTRADIOL, ESTRADIOL
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE
AM ANTIBIOTICS
* AMERICAN ANTIBIOTICS INC
AMOXICILLIN, AMOXICILLIN
AM REGENT
* AMERICAN REGENT INC
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CYANOCOBALAMIN, CYANOCOBALAMIN
CYCLOSPORINE, CYCLOSPORINE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
ESTRADIOL VALERATE, ESTRADIOL VALERATE
FOMEPIZOLE, FOMEPIZOLE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROXYPROGESTERON CAPROATE, HYDROXYPROGESTERONE CAPROATE
HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE
INJECTAFER, FERRIC CARBOXYMALTOSE
METHOCARBAMOL, METHOCARBAMOL
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
OLANZAPINE, OLANZAPINE
SELENIOUS ACID, SELENIOUS ACID
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
VENOFER, IRON SUCROSE
ZINC SULFATE, ZINC SULFATE
AMAG PHARMA USA
* AMAG PHARMA USA INC
MAKENA (AUTOINJECTOR), HYDROXYPROGESTERONE CAPROATE
MAKENA PRESERVATIVE FREE, HYDROXYPROGESTERONE CAPROATE
MAKENA, HYDROXYPROGESTERONE CAPROATE
AMAG PHARMS INC
* AMAG PHARMACEUTICALS INC
FERAHEME, FERUMOXYTOL
INTRAROSA, PRASTERONE
VYLEESI (AUTOINJECTOR), BREMELANOTIDE ACETATE
AMARIN PHARMS
* AMARIN PHARMACEUTICALS IRELAND LTD
VASCEPA, ICOSAPENT ETHYL
AMERIGEN PHARMS LTD
* AMERIGEN PHARMACEUTICALS LTD
BEXAROTENE, BEXAROTENE
CARBIDOPA, CARBIDOPA
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
INDAPAMIDE, INDAPAMIDE
MIGLUSTAT, MIGLUSTAT
PENICILLAMINE, PENICILLAMINE
RANOLAZINE, RANOLAZINE
TEMOZOLOMIDE, TEMOZOLOMIDE
AMGEN
* AMGEN INC
SENSIPAR, CINACALCET HYDROCHLORIDE
AMGEN INC
* AMGEN INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 18

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AMGEN INC
CORLANOR, IVABRADINE
CORLANOR, IVABRADINE HYDROCHLORIDE
OTEZLA, APREMILAST
AMICI
* AMICI PHARMACEUTICALS LLC
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
AMICUS THERAPS US
* AMICUS THERAPEUTICS US INC
GALAFOLD, MIGALASTAT HYDROCHLORIDE
AMNEAL
* AMNEAL EU LTD
AMINOCAPROIC ACID, AMINOCAPROIC ACID
BUSULFAN, BUSULFAN
CARMUSTINE, CARMUSTINE
CLOFARABINE, CLOFARABINE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DOCETAXEL, DOCETAXEL
DOXERCALCIFEROL, DOXERCALCIFEROL
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
EPHEDRINE SULFATE, EPHEDRINE SULFATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FULVESTRANT, FULVESTRANT
GLYCOPYRROLATE, GLYCOPYRROLATE
ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE
LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
OFLOXACIN, OFLOXACIN
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE
SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
AMNEAL PHARM
* AMNEAL PHARMACEUTICAL
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FOLIC ACID, FOLIC ACID
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
AMNEAL PHARMS
* AMNEAL PHARMACEUTICALS
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ARIPIPRAZOLE, ARIPIPRAZOLE
ATOVAQUONE, ATOVAQUONE
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE
CAPECITABINE, CAPECITABINE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DIVALPROEX SODIUM, DIVALPROEX SODIUM
ENTECAVIR, ENTECAVIR
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 19

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AMNEAL PHARMACEUTICALS
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESTRADIOL, ESTRADIOL
FELBAMATE, FELBAMATE
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
INDOMETHACIN, INDOMETHACIN
ITRACONAZOLE, ITRACONAZOLE
LEVETIRACETAM, LEVETIRACETAM
LIDOCAINE, LIDOCAINE
LINEZOLID, LINEZOLID
LORAZEPAM, LORAZEPAM
MEROPENEM, MEROPENEM
METAXALONE, METAXALONE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NIACIN, NIACIN
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NITROFURANTOIN, NITROFURANTOIN
NIZATIDINE, NIZATIDINE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE
QUININE SULFATE, QUININE SULFATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TELMISARTAN, TELMISARTAN
TEMAZEPAM, TEMAZEPAM
TEMOZOLOMIDE, TEMOZOLOMIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
WARFARIN SODIUM, WARFARIN SODIUM
* AMNEAL PHARMACEUTICALS HOLDINGS GMBH
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
* AMNEAL PHARMACEUTICALS OF NEW YORK LLC
ABIRATERONE ACETATE, ABIRATERONE ACETATE
ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUDESONIDE, BUDESONIDE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CELECOXIB, CELECOXIB
DUTASTERIDE, DUTASTERIDE
EPTIFIBATIDE, EPTIFIBATIDE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
GUAIFENESIN, GUAIFENESIN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
IRBESARTAN, IRBESARTAN
LAMOTRIGINE, LAMOTRIGINE
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL (OTC)
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 20

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AMNEAL PHARMACEUTICALS OF NEW YORK LLC
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PALIPERIDONE, PALIPERIDONE
PARICALCITOL, PARICALCITOL
PRASUGREL, PRASUGREL HYDROCHLORIDE
RIVASTIGMINE, RIVASTIGMINE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SPIRONOLACTONE, SPIRONOLACTONE
TOBRAMYCIN, TOBRAMYCIN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VALSARTAN, VALSARTAN
VIGABATRIN, VIGABATRIN
AMNEAL PHARMS CO
* AMNEAL PHARMACEUTICALS CO GMBH
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ARGATROBAN, ARGATROBAN
BOSENTAN, BOSENTAN
BUMETANIDE, BUMETANIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CHLORTHALIDONE, CHLORTHALIDONE
CLOBAZAM, CLOBAZAM
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
DEFERASIROX, DEFERASIROX
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE
ERYTHROMYCIN, ERYTHROMYCIN
ETHACRYNIC ACID, ETHACRYNIC ACID
ETODOLAC, ETODOLAC
EZETIMIBE AND SIMVASTATIN, EZETIMIBE
EZETIMIBE, EZETIMIBE
FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE
FUROSEMIDE, FUROSEMIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
NADOLOL, NADOLOL
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
OXAPROZIN, OXAPROZIN
PARICALCITOL, PARICALCITOL
PHYTONADIONE, PHYTONADIONE
PREGABALIN, PREGABALIN
SEVELAMER CARBONATE, SEVELAMER CARBONATE
SILODOSIN, SILODOSIN
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
TADALAFIL, TADALAFIL
TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
URSODIOL, URSODIOL
AMNEAL PHARMS LLC
* AMNEAL PHARMACEUTICALS LLC
ACTIVELLA, ESTRADIOL
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AZATHIOPRINE, AZATHIOPRINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 21

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AMNEAL PHARMACEUTICALS LLC
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
CLOBAZAM, CLOBAZAM
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)
ELURYNG, ETHINYL ESTRADIOL
ESTRADIOL, ESTRADIOL
FENOFIBRATE, FENOFIBRATE
FLUOCINONIDE, FLUOCINONIDE
MESALAMINE, MESALAMINE
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RITONAVIR, RITONAVIR
SIROLIMUS, SIROLIMUS
SUCRALFATE, SUCRALFATE
TESTOSTERONE, TESTOSTERONE
TIGECYCLINE, TIGECYCLINE
TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE
AMNEAL PHARMS NY
* AMNEAL PHARMACEUTICALS NY LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALPRAZOLAM, ALPRAZOLAM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REPREXAIN, HYDROCODONE BITARTRATE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
* AMNEAL PHARMACEUTICALS OF NY LLC
BEXAROTENE, BEXAROTENE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
ISOTRETINOIN, ISOTRETINOIN
OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE
PROGESTERONE, PROGESTERONE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
AMPHASTAR PHARM
* AMPHASTAR PHARMACEUTICAL INC
AMPHADASE, HYALURONIDASE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
AMPHASTAR PHARMS INC
* AMPHASTAR PHARMACEUTICALS INC
CORTROSYN, COSYNTROPIN
ENOXAPARIN SODIUM, ENOXAPARIN SODIUM
ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 22

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
AMRING PHARMS
* AMRING PHARMACEUTICALS INC
ARSENIC TRIOXIDE, ARSENIC TRIOXIDE
LATANOPROST, LATANOPROST
MESALAMINE, MESALAMINE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE
AMTA
* AMTA LABS LTD
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
ANACOR PHARMS INC
* ANACOR PHARMACEUTICALS INC
EUCRISA, CRISABOROLE
KERYDIN, TAVABOROLE
ANBEX
* ANBEX INC
IOSAT, POTASSIUM IODIDE (OTC)
ANBISON LAB
* ANBISON LABORATORY CO LTD
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
ANCHEN PHARMS
* ANCHEN PHARMACEUTICALS INC
ALISKIREN HEMIFUMARATE, ALISKIREN HEMIFUMARATE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRETINOIN, TRETINOIN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* ANCHEN PHARMACEUTICALS TAIWAN INC
DIVALPROEX SODIUM, DIVALPROEX SODIUM
* ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM, ALPRAZOLAM
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
ANDA REPOSITORY
* ANDA REPOSITORY LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CICLOPIROX, CICLOPIROX
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
FLAC, FLUOCINOLONE ACETONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
IMIQUIMOD, IMIQUIMOD
ISONIAZID, ISONIAZID
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 23

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ANDA REPOSITORY LLC
LEVETIRACETAM, LEVETIRACETAM
MOMETASONE FUROATE, MOMETASONE FUROATE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PRIMIDONE, PRIMIDONE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
ANDOR PHARMS
* ANDOR PHARMACEUTICALS LLC
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
ANI PHARMS
* ANI PHARMACEUTICALS INC
CORTENEMA, HYDROCORTISONE
LUVOX, FLUVOXAMINE MALEATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ANI PHARMS INC
* ANI PHARMACEUTICALS INC
ARIMIDEX, ANASTROZOLE
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
BRETHINE, TERBUTALINE SULFATE
CASODEX, BICALUTAMIDE
CHOLESTYRAMINE, CHOLESTYRAMINE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
ETODOLAC, ETODOLAC
EZETIMIBE AND SIMVASTATIN, EZETIMIBE
FELBAMATE, FELBAMATE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
INDAPAMIDE, INDAPAMIDE
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
LITHOBID, LITHIUM CARBONATE
METHAZOLAMIDE, METHAZOLAMIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NILUTAMIDE, NILUTAMIDE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PINDOLOL, PINDOLOL
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
POTASSIUM CITRATE, POTASSIUM CITRATE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ANIMA
* ANIMA PHARMACEUTICALS PVT LTD
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
DEXAMETHASONE, DEXAMETHASONE
ANNORA
* ANNORA PHARMA PRIVATE LTD
LAMIVUDINE, LAMIVUDINE
ANNORA PHARMA
* ANNORA PHARMA PRIVATE LTD
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ANTARES PHARMA INC
* ANTARES PHARMA INC
OTREXUP, METHOTREXATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
XYOSTED (AUTOINJECTOR), TESTOSTERONE ENANTHATE
ANTIBIOTICE
* ANTIBIOTICE SA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 24

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ANTIBIOTICE SA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM
APEX PHARMS INC
* APEX PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
APGDI
* ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
MYRBETRIQ, MIRABEGRON
APIL
* ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
ACTONEL, RISEDRONATE SODIUM
ASACOL HD, MESALAMINE
ATELVIA, RISEDRONATE SODIUM
DELZICOL, MESALAMINE
ENABLEX, DARIFENACIN HYDROBROMIDE
ESTROSTEP FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
LO LOESTRIN FE, ETHINYL ESTRADIOL
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
MINASTRIN 24 FE, ETHINYL ESTRADIOL
NOR-QD, NORETHINDRONE
NORCO, ACETAMINOPHEN
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
SARAFEM, FLUOXETINE HYDROCHLORIDE
TAYTULLA, ETHINYL ESTRADIOL
APNAR PHARMA LP
* APNAR PHARMA LP
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
APOLLO
* APOLLO PHARMACEUTICALS INC
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
TRANEXAMIC ACID, TRANEXAMIC ACID
APOPHARMA INC
* APOPHARMA INC
FERRIPROX, DEFERIPRONE
APOTEX
* APOTEX INC
ABIRATERONE ACETATE, ABIRATERONE ACETATE
ACYCLOVIR, ACYCLOVIR
ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORIDE
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
ATOVAQUONE, ATOVAQUONE
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, AZELASTINE HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BIVALIRUDIN, BIVALIRUDIN
BUSULFAN, BUSULFAN
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 25

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* APOTEX INC
CIMETIDINE, CIMETIDINE (OTC)
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOSPORINE, CYCLOSPORINE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPLERENONE, EPLERENONE
ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE
ETODOLAC, ETODOLAC
EZETIMIBE, EZETIMIBE
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
GLIPIZIDE, GLIPIZIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IMATINIB MESYLATE, IMATINIB MESYLATE
ITRACONAZOLE, ITRACONAZOLE
LAMIVUDINE, LAMIVUDINE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SIROLIMUS, SIROLIMUS
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIGECYCLINE, TIGECYCLINE
TIMOLOL MALEATE, TIMOLOL MALEATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TRAVOPROST, TRAVOPROST
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 26

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
APOTEX CORP
* APOTEX CORP
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RILUZOLE, RILUZOLE
APOTEX INC
* APOTEX INC
ABACAVIR SULFATE, ABACAVIR SULFATE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
ANASTROZOLE, ANASTROZOLE
ARIPIPRAZOLE, ARIPIPRAZOLE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BENZONATATE, BENZONATATE
BICALUTAMIDE, BICALUTAMIDE
BIMATOPROST, BIMATOPROST
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CALCITONIN-SALMON, CALCITONIN SALMON
CARBAMAZEPINE, CARBAMAZEPINE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFPROZIL, CEFPROZIL
CELECOXIB, CELECOXIB
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DUTASTERIDE, DUTASTERIDE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IMIQUIMOD, IMIQUIMOD
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LOVASTATIN, LOVASTATIN
MODAFINIL, MODAFINIL
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERIDONE, RISPERIDONE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* APOTEX INC ETOBICOKE SITE
ACYCLOVIR, ACYCLOVIR
ALLOPURINOL, ALLOPURINOL
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBAMAZEPINE, CARBAMAZEPINE
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 27

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* APOTEX INC ETOBICOKE SITE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DILTZAC, DILTIAZEM HYDROCHLORIDE
ETODOLAC, ETODOLAC
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
LEFLUNOMIDE, LEFLUNOMIDE
LISINOPRIL, LISINOPRIL
LORATADINE, LORATADINE (OTC)
MELOXICAM, MELOXICAM
MIRTAZAPINE, MIRTAZAPINE
OXAPROZIN, OXAPROZIN
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
ZONISAMIDE, ZONISAMIDE
* APOTEX INC RICHMOND HILL
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BUDESONIDE, BUDESONIDE (OTC)
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
* APOTEX INC.
DILTZAC, DILTIAZEM HYDROCHLORIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
APOTEX TECHNOLOGIES
* APOTEX TECHNOLOGIES INC
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
APOTHECON
* APOTHECON INC DIV BRISTOL MYERS SQUIBB
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
KENALOG-80, TRIAMCINOLONE ACETONIDE
APP PHARMS
* APP PHARMACEUTICALS LLC
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
APPCO
* APPCO PHARMA LLC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BUDESONIDE, BUDESONIDE
HALOPERIDOL, HALOPERIDOL
METAXALONE, METAXALONE
MODAFINIL, MODAFINIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
APRECIA PHARMS
* APRECIA PHARMACEUTICALS LLC
SPRITAM, LEVETIRACETAM
APTAPHARMA INC
* APTAPHARMA INC
IBUPROFEN, IBUPROFEN (OTC)
AQUESTIVE THERAP
* AQUESTIVE THERAPEUTICS
EXSERVAN, RILUZOLE
SYMPAZAN, CLOBAZAM
ARBOR PHARMS LLC
* ARBOR PHARMACEUTICALS LLC
BIDIL, HYDRALAZINE HYDROCHLORIDE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
EDARBI, AZILSARTAN KAMEDOXOMIL
EDARBYCLOR, AZILSARTAN KAMEDOXOMIL
ERY-TAB, ERYTHROMYCIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 28

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ARBOR PHARMACEUTICALS LLC
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN, ERYTHROMYCIN
EVEKEO ODT, AMPHETAMINE SULFATE
EVEKEO, AMPHETAMINE SULFATE
GLIADEL, CARMUSTINE
HORIZANT, GABAPENTIN ENACARBIL
NYMALIZE, NIMODIPINE
SKLICE, IVERMECTIN
SOTYLIZE, SOTALOL HYDROCHLORIDE
TRIPTODUR KIT, TRIPTORELIN PAMOATE
ARCO PHARMS LLC
* ARCO PHARMACEUTICALS LLC
THYROSHIELD, POTASSIUM IODIDE (OTC)
ARDELYX INC
* ARDELYX INC
IBSRELA, TENAPANOR HYDROCHLORIDE
AREVA PHARMS
* AREVA PHARMACEUTICALS INC
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
ARIAD
* ARIAD PHARMACEUTICALS INC
ALUNBRIG, BRIGATINIB
ICLUSIG, PONATINIB HYDROCHLORIDE
ARISE
* ARISE PHARMACEUTICALS LLC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
CHLORTHALIDONE, CHLORTHALIDONE
IBUPROFEN, IBUPROFEN (OTC)
LAMIVUDINE, LAMIVUDINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
ARMSTRONG PHARMS
* ARMSTRONG PHARMACEUTICALS INC
PRIMATENE MIST, EPINEPHRINE (OTC)
ARRAY BIOPHARMA INC
* ARRAY BIOPHARMA INC
BRAFTOVI, ENCORAFENIB
MEKTOVI, BINIMETINIB
ASCEND THERAPS US
* ASCEND THERAPEUTICS US LLC
BINOSTO, ALENDRONATE SODIUM
ESTROGEL, ESTRADIOL
ASCENT PHARMS INC
* ASCENT PHARMACEUTICALS INC
BENZONATATE, BENZONATATE
DUTASTERIDE, DUTASTERIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IBUPROFEN, IBUPROFEN (OTC)
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
ASPEN
* ASPEN PHARMA USA INC
HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE
ASPEN GLOBAL
* ASPEN GLOBAL INC
MYLERAN, BUSULFAN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 29

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
ASPEN GLOBAL INC
* ASPEN GLOBAL INC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CYCLESSA, DESOGESTREL
HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE
LEUKERAN, CHLORAMBUCIL
THIOGUANINE, THIOGUANINE
ASSERTIO
* ASSERTIO THERAPEUTICS INC
CAMBIA, DICLOFENAC POTASSIUM
GRALISE, GABAPENTIN
ZIPSOR, DICLOFENAC POTASSIUM
ASTELLAS
* ASTELLAS PHARMA US INC
AMBISOME, AMPHOTERICIN B
ASTAGRAF XL, TACROLIMUS
CRESEMBA, ISAVUCONAZONIUM SULFATE
LEXISCAN, REGADENOSON
MYCAMINE, MICAFUNGIN SODIUM
PROGRAF, TACROLIMUS
VESICARE, SOLIFENACIN SUCCINATE
XOSPATA, GILTERITINIB FUMARATE
XTANDI, ENZALUTAMIDE
ASTRAL
* ASTRAL STERITECH PVT LTD
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
ASTRAZENECA
* ASTRAZENECA LP
PULMICORT FLEXHALER, BUDESONIDE
SYMBICORT, BUDESONIDE
* ASTRAZENECA PHARMACEUTICALS LP
FASLODEX, FULVESTRANT
ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN
* ASTRAZENECA UK LTD
CALQUENCE, ACALABRUTINIB
SEROQUEL XR, QUETIAPINE FUMARATE
ASTRAZENECA AB
* ASTRAZENECA AB
BYDUREON BCISE, EXENATIDE
BYDUREON PEN, EXENATIDE SYNTHETIC
BYDUREON, EXENATIDE SYNTHETIC
BYETTA, EXENATIDE SYNTHETIC
FARXIGA, DAPAGLIFLOZIN
KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
QTERN, DAPAGLIFLOZIN
QTERNMET XR, DAPAGLIFLOZIN
SYMLIN, PRAMLINTIDE ACETATE
XIGDUO XR, DAPAGLIFLOZIN
ASTRAZENECA LP
* ASTRAZENECA LP
NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC)
ASTRAZENECA PHARMS
* ASTRAZENECA PHARMACEUTICALS LP
BEVESPI AEROSPHERE, FORMOTEROL FUMARATE
BRILINTA, TICAGRELOR
DALIRESP, ROFLUMILAST
IRESSA, GEFITINIB
LOKELMA, SODIUM ZIRCONIUM CYCLOSILICATE
LYNPARZA, OLAPARIB
MOVANTIK, NALOXEGOL OXALATE
NEXIUM IV, ESOMEPRAZOLE SODIUM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 30

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* ASTRAZENECA PHARMACEUTICALS LP
NEXIUM, ESOMEPRAZOLE MAGNESIUM
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)
PULMICORT RESPULES, BUDESONIDE
RHINOCORT ALLERGY, BUDESONIDE (OTC)
SEROQUEL, QUETIAPINE FUMARATE
TAGRISSO, OSIMERTINIB MESYLATE
ATHEM
* ATHEM HOLDINGS LLC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHLORTHALIDONE, CHLORTHALIDONE
FOLIC ACID, FOLIC ACID
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
ATHENA
* ATHENA BIOSCIENCES LLC
FIBRICOR, FENOFIBRIC ACID
ATHENEX
* ATHENEX PHARMACEUTICAL DIV
PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM
ATHENEX INC
* ATHENEX INC
BUSULFAN, BUSULFAN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
VALPROATE SODIUM, VALPROATE SODIUM
ATLAS PHARMS LLC
* ATLAS PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ATNAHS PHARMA US
* ATNAHS PHARMA US LTD
ANAPROX DS, NAPROXEN SODIUM
EC-NAPROSYN, NAPROXEN
NAPROSYN, NAPROXEN
ATON
* ATON PHARMA INC
LODOSYN, CARBIDOPA
AUCTA
* AUCTA PHARMACEUTICALS INC
VIGADRONE, VIGABATRIN
AUREX
* AUREX LABORATORIES LTD LIABILITY CO
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
AUROBINDO
* AUROBINDO PHARMA LTD
AMOXICILLIN, AMOXICILLIN
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
NEVIRAPINE, NEVIRAPINE
ZIDOVUDINE, ZIDOVUDINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 31

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
AUROBINDO PHARMA
* AUROBINDO PHARMA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
* AUROBINDO PHARMA LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMPICILLIN SODIUM, AMPICILLIN SODIUM
ATENOLOL, ATENOLOL
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
CARISOPRODOL, CARISOPRODOL
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MELOXICAM, MELOXICAM
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RIBAVIRIN, RIBAVIRIN
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
STAVUDINE, STAVUDINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRANDOLAPRIL, TRANDOLAPRIL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
AUROBINDO PHARMA LTD
* AUROBINDO PHARMA LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LEVOFLOXACIN, LEVOFLOXACIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
* AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 32

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AUROBINDO PHARMA LTD
ABACAVIR SULFATE, ABACAVIR SULFATE
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETYLCYSTEINE, ACETYLCYSTEINE
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
AFIRMELLE, ETHINYL ESTRADIOL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
ARIPIPRAZOLE, ARIPIPRAZOLE
ARMODAFINIL, ARMODAFINIL
ATAZANAVIR SULFATE, ATAZANAVIR SULFATE
ATHENTIA NEXT, LEVONORGESTREL (OTC)
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
AUROVELA 1.5/30, ETHINYL ESTRADIOL
AUROVELA 1/20, ETHINYL ESTRADIOL
AUROVELA 24 FE, ETHINYL ESTRADIOL
AUROVELA FE 1.5/30, ETHINYL ESTRADIOL
AUROVELA FE 1/20, ETHINYL ESTRADIOL
AYUNA, ETHINYL ESTRADIOL
AZITHROMYCIN, AZITHROMYCIN
BIVALIRUDIN, BIVALIRUDIN
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CARBIDOPA, CARBIDOPA
CEFIXIME, CEFIXIME
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CELECOXIB, CELECOXIB
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CLOZAPINE, CLOZAPINE
CYONANZ, ETHINYL ESTRADIOL
DALFAMPRIDINE, DALFAMPRIDINE
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOFETILDE, DOFETILIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
EFAVIRENZ, EFAVIRENZ
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ
ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 33

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AUROBINDO PHARMA LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE
ENTACAPONE, ENTACAPONE
ENTECAVIR, ENTECAVIR
EPTIFIBATIDE, EPTIFIBATIDE
ERTAPENEM SODIUM, ERTAPENEM SODIUM
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
ESZOPICLONE, ESZOPICLONE
ETOMIDATE, ETOMIDATE
EZETIMIBE, EZETIMIBE
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FESOTERODINE FUMARATE, FESOTERODINE FUMARATE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FINASTERIDE, FINASTERIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
GUAIFENESIN, GUAIFENESIN (OTC)
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
ICLEVIA, ETHINYL ESTRADIOL
INCASSIA, NORETHINDRONE
INDOMETHACIN, INDOMETHACIN
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
ISOSULFAN BLUE, ISOSULFAN BLUE
KALLIGA, DESOGESTREL
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LATANOPROST, LATANOPROST
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LINEZOLID, LINEZOLID
LO SIMPESSE, ETHINYL ESTRADIOL
LO-ZUMANDIMINE, DROSPIRENONE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORATADINE, LORATADINE (OTC)
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 34

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AUROBINDO PHARMA LTD
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHENAMINE HIPPURATE, METHENAMINE HIPPURATE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METRONIDAZOLE, METRONIDAZOLE
MILI, ETHINYL ESTRADIOL
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MODAFINIL, MODAFINIL
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NADOLOL, NADOLOL
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
NEVIRAPINE, NEVIRAPINE
NEXESTA FE, ETHINYL ESTRADIOL
NIACIN, NIACIN
NYLIA 1/35, ETHINYL ESTRADIOL
NYLIA 7/7/7, ETHINYL ESTRADIOL
OLANZAPINE, OLANZAPINE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXACILLIN SODIUM, OXACILLIN SODIUM
PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PARICALCITOL, PARICALCITOL
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRASUGREL, PRASUGREL HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
REPAGLINIDE, REPAGLINIDE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERIDONE, RISPERIDONE
RITONAVIR, RITONAVIR
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 35

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
SEVELAMER CARBONATE, SEVELAMER CARBONATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SILODOSIN, SILODOSIN
SIMPESSE, ETHINYL ESTRADIOL
SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TADALAFIL, TADALAFIL
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TELMISARTAN, TELMISARTAN
TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE
TIGECYCLINE, TIGECYCLINE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TRI-LO-MILI, ETHINYL ESTRADIOL
TRI-MILI, ETHINYL ESTRADIOL
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSARTAN, VALSARTAN
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VORICONAZOLE, VORICONAZOLE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ZOLMITRIPTAN, ZOLMITRIPTAN
ZUMANDIMINE, DROSPIRENONE
* AUROBINDO PHARMA LTD INC
ZIDOVUDINE, ZIDOVUDINE
AUROLIFE PHARMA LLC
* AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DUTASTERIDE, DUTASTERIDE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
AUSTARPHARMA
* AUSTARPHARMA LLC
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
AUSTARPHARMA LLC
* AUSTARPHARMA LLC
METHOCARBAMOL, METHOCARBAMOL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
AUXILIUM PHARMS INC
* AUXILIUM PHARMACEUTICALS INC
TESTOPEL, TESTOSTERONE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 36

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AUXILIUM PHARMACEUTICALS INC
THEO-24, THEOPHYLLINE
AUXILIUM PHARMS LLC
* AUXILIUM PHARMACEUTICALS LLC
DILATRATE-SR, ISOSORBIDE DINITRATE
EDEX, ALPROSTADIL
ROBAXIN-750, METHOCARBAMOL
SEMPREX-D, ACRIVASTINE
TESTIM, TESTOSTERONE
THEO-24, THEOPHYLLINE
AVACOR PRODS
* AVACOR PRODUCTS LLC
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
AVADEL LEGACY
* AVADEL LEGACY PHARMACEUTICALS LLC
AKOVAZ, EPHEDRINE SULFATE
BLOXIVERZ, NEOSTIGMINE METHYLSULFATE
NOURESS, CYSTEINE HYDROCHLORIDE
VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE
AVANIR PHARMS
* AVANIR PHARMACEUTICALS INC
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE
AVANTHI INC
* AVANTHI INC
CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE
INDOMETHACIN, INDOMETHACIN
LOMAIRA, PHENTERMINE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
AVEDRO INC
* AVEDRO INC
PHOTREXA VISCOUS IN DEXTRAN 20%, RIBOFLAVIN 5'-PHOSPHATE SODIUM
PHOTREXA, RIBOFLAVIN 5'-PHOSPHATE SODIUM
AVEMA PHARMA
* AVEMA PHARMA SOLUTIONS
IBUPROFEN, IBUPROFEN (OTC)
AVENT
* AVENT INC
PYTEST KIT, UREA, C-14
PYTEST, UREA, C-14
AVERITAS
* AVERITAS PHARMA INC
QUTENZA, CAPSAICIN
AVET
* AVET PHARMACEUTICALS INC
ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE
FUROSEMIDE, FUROSEMIDE
AVEVA
* AVEVA DRUG DELIVERY SYSTEMS INC
CLONIDINE, CLONIDINE
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-37, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-62, FENTANYL
FENTANYL-75, FENTANYL
FENTANYL-87, FENTANYL
NICOTINE, NICOTINE (OTC)
AVID RADIOPHARMS INC
* AVID RADIOPHARMACEUTICALS INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 37

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **
* AVID RADIOPHARMACEUTICALS INC
AMYVID, FLORBETAPIR F-18
AVION PHARMS
* AVION PHARMACEUTICALS LLC
BALCOLTRA, ETHINYL ESTRADIOL
GLOPERBA, COLCHICINE
AVONDALE PHARMS
* AVONDALE PHARMACEUTICALS LLC
NIACOR, NIACIN
AYTU
* AYTU BIOSCIENCE INC
ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM
KARBINAL ER, CARBINOXAMINE MALEATE
TUZISTRA XR, CHLORPHENIRAMINE POLISTIREX
ZOLPIMIST, ZOLPIDEM TARTRATE
** B **
B BRAUN
* B BRAUN MEDICAL INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
AMINO ACIDS, AMINO ACIDS
BALANCED SALT, CALCIUM CHLORIDE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM
CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 38

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* B BRAUN MEDICAL INC
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
NEPHRAMINE 5.4%, AMINO ACIDS
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 39

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* B BRAUN MEDICAL INC
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROCALAMINE, AMINO ACIDS
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
B BRAUN MEDICAL INC
* B BRAUN MEDICAL INC
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
CLOROTEKAL, CHLOROPROCAINE HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM
BAJAJ
* BAJAJ MEDICAL LLC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
BARR
* BARR LABORATORIES INC
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ARANELLE, ETHINYL ESTRADIOL
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
BALZIVA-28, ETHINYL ESTRADIOL
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
DANAZOL, DANAZOL
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DIAZEPAM, DIAZEPAM
DIPYRIDAMOLE, DIPYRIDAMOLE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DUTASTERIDE, DUTASTERIDE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
ESTRADIOL AND NORGESTIMATE, ESTRADIOL
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDROXYUREA, HYDROXYUREA
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
ISONIAZID, ISONIAZID
JUNEL 1.5/30, ETHINYL ESTRADIOL
JUNEL 1/20, ETHINYL ESTRADIOL
JUNEL FE 1.5/30, ETHINYL ESTRADIOL
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 40

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BARR LABORATORIES INC
JUNEL FE 1/20, ETHINYL ESTRADIOL
KARIVA, DESOGESTREL
KELNOR, ETHINYL ESTRADIOL
LEFLUNOMIDE, LEFLUNOMIDE
LESSINA-28, ETHINYL ESTRADIOL
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NIACIN, NIACIN
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORTREL 0.5/35-28, ETHINYL ESTRADIOL
NORTREL 1/35-21, ETHINYL ESTRADIOL
NORTREL 1/35-28, ETHINYL ESTRADIOL
NORTREL 7/7/7, ETHINYL ESTRADIOL
ONDANSETRON, ONDANSETRON
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PORTIA-28, ETHINYL ESTRADIOL
SPRINTEC, ETHINYL ESTRADIOL
TEMOZOLOMIDE, TEMOZOLOMIDE
TREXALL, METHOTREXATE SODIUM
TRI-LEGEST 21, ETHINYL ESTRADIOL
TRI-LEGEST FE, ETHINYL ESTRADIOL
TRI-SPRINTEC, ETHINYL ESTRADIOL
WARFARIN SODIUM, WARFARIN SODIUM
* BARR PHARMACEUTICALS
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
BARR LABS DIV TEVA
* BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA
BUDESONIDE, BUDESONIDE
BARR LABS INC
* BARR LABORATORIES INC
ACITRETIN, ACITRETIN
CLOZAPINE, CLOZAPINE
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
ESTRADIOL, ESTRADIOL
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OLANZAPINE, OLANZAPINE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
TRETINOIN, TRETINOIN
TRI LO SPRINTEC, ETHINYL ESTRADIOL
BAUSCH
* BAUSCH HEALTH AMERICAS INC
ACANYA, BENZOYL PEROXIDE
ARAZLO, TAZAROTENE
BENZACLIN, BENZOYL PEROXIDE
BRYHALI, HALOBETASOL PROPIONATE
DUOBRII, HALOBETASOL PROPIONATE
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
EFUDEX, FLUOROURACIL
JUBLIA, EFINACONAZOLE
LOCOID, HYDROCORTISONE BUTYRATE
MEPHYTON, PHYTONADIONE
ONEXTON, BENZOYL PEROXIDE
OXSORALEN-ULTRA, METHOXSALEN
SYPRINE, TRIENTINE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 41

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BAUSCH HEALTH IRELAND LTD
ERTACZO, SERTACONAZOLE NITRATE
TARGRETIN, BEXAROTENE
TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE
* BAUSCH HEALTH US LLC
ALDARA, IMIQUIMOD
ANCOBON, FLUCYTOSINE
ATIVAN, LORAZEPAM
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
CLINDAGEL, CLINDAMYCIN PHOSPHATE
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE
DEMSER, METYROSINE
DIASTAT ACUDIAL, DIAZEPAM
DIASTAT, DIAZEPAM
ELIDEL, PIMECROLIMUS
ISORDIL, ISOSORBIDE DINITRATE
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
LOCOID, HYDROCORTISONE BUTYRATE
LOPROX, CICLOPIROX
MESTINON, PYRIDOSTIGMINE BROMIDE
METROGEL-VAGINAL, METRONIDAZOLE
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
MINOCIN, MINOCYCLINE HYDROCHLORIDE
TASMAR, TOLCAPONE
TIAZAC, DILTIAZEM HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOTEC, ENALAPRIL MALEATE
XERESE, ACYCLOVIR
ZELAPAR, SELEGILINE HYDROCHLORIDE
ZOVIRAX, ACYCLOVIR
ZYCLARA, IMIQUIMOD
BAUSCH AND LOMB
* BAUSCH AND LOMB INC
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALREX, LOTEPREDNOL ETABONATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
ISTALOL, TIMOLOL MALEATE
LATANOPROST, LATANOPROST
LOTEMAX, LOTEPREDNOL ETABONATE
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
OFLOXACIN, OFLOXACIN
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
PROLENSA, BROMFENAC SODIUM
RETISERT, FLUOCINOLONE ACETONIDE
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
TIMOLOL MALEATE, TIMOLOL MALEATE
TROPICAMIDE, TROPICAMIDE
VITRASE, HYALURONIDASE
VYZULTA, LATANOPROSTENE BUNOD
ZIRGAN, GANCICLOVIR
ZYLET, LOTEPREDNOL ETABONATE
* BAUSCH AND LOMB PHARMACEUTICALS INC
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 42

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BAUSCH AND LOMB PHARMACEUTICALS INC
DEXASPORIN, DEXAMETHASONE
ERYTHROMYCIN, ERYTHROMYCIN
FLUNISOLIDE, FLUNISOLIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
OTICAIR, HYDROCORTISONE
PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TIMOLOL MALEATE, TIMOLOL MALEATE
TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCIN, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
TROPICAMIDE, TROPICAMIDE
BAUSCH AND LOMB INC
* BAUSCH AND LOMB INC
BEPREVE, BEPOTASTINE BESILATE
LOTEMAX SM, LOTEPREDNOL ETABONATE
LOTEMAX, LOTEPREDNOL ETABONATE
LUMIFY, BRIMONIDINE TARTRATE (OTC)
BAXTER HLTHCARE
* BAXTER HEALTHCARE CORP
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC
CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 43

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BAXTER HEALTHCARE CORP
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
EXTRANEAL, ICODEXTRIN
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FORANE, ISOFLURANE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
IFEX, IFOSFAMIDE
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
MESNEX, MESNA
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM
NEXTERONE, AMIODARONE HYDROCHLORIDE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 10% IN WATER, MANNITOL
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 44

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BAXTER HEALTHCARE CORP
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SEVOFLURANE, SEVOFLURANE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
STERILE WATER, STERILE WATER FOR IRRIGATION
SUPRANE, DESFLURANE
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIS-U-SOL, MAGNESIUM SULFATE
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
BAXTER HLTHCARE CORP
* BAXTER HEALTHCARE CORP
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, BIVALIRUDIN
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CLINOLIPID 20%, OLIVE OIL
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 45

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BAXTER HEALTHCARE CORP
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
EPTIFIBATIDE, EPTIFIBATIDE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE
FUROSEMIDE, FUROSEMIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOFLOXACIN, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MYXREDLIN, INSULIN HUMAN
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
BAYER
* BAYER HEALTHCARE LLC
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)
BAYER HEALTHCARE
* BAYER HEALTHCARE PHARMACEUTICALS INC
ALIQOPA, COPANLISIB DIHYDROCHLORIDE
NUBEQA, DAROLUTAMIDE
VITRAKVI, LAROTRECTINIB SULFATE
BAYER HEALTHCARE LLC
* BAYER HEALTHCARE LLC
CHILDREN'S CLARITIN, LORATADINE (OTC)
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
CLARITIN-D, LORATADINE (OTC)
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
ZEGERID OTC, OMEPRAZOLE (OTC)
BAYER HLTHCARE
* BAYER HEALTHCARE CONSUMER CARE
ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
* BAYER HEALTHCARE PHARMACEUTICALS INC
ADEMPAS, RIOCIGUAT
ANGELIQ, DROSPIRENONE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
BEYAZ, DROSPIRENONE
BILTRICIDE, PRAZIQUANTEL
CIPRO, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
CLIMARA PRO, ESTRADIOL
CLIMARA, ESTRADIOL
EOVIST, GADOXETATE DISODIUM
GADAVIST, GADOBUTROL
KYLEENA, LEVONORGESTREL
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 46

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BAYER HEALTHCARE PHARMACEUTICALS INC
LEVITRA, VARDENAFIL HYDROCHLORIDE
MENOSTAR, ESTRADIOL
MIRENA, LEVONORGESTREL
NATAZIA, DIENOGEST
NEXAVAR, SORAFENIB TOSYLATE
SAFYRAL, DROSPIRENONE
SKYLA, LEVONORGESTREL
STAXYN, VARDENAFIL HYDROCHLORIDE
STIVARGA, REGORAFENIB
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
VITRAKVI, LAROTRECTINIB SULFATE
XOFIGO, RADIUM RA-223 DICHLORIDE
YASMIN, DROSPIRENONE
YAZ, DROSPIRENONE
BAYSHORE PHARMS LLC
* BAYSHORE PHARMACEUTICALS LLC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
PINDOLOL, PINDOLOL
PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE
BDSI
* BIODELIVERY SCIENCES INTERNATIONAL INC
BELBUCA, BUPRENORPHINE HYDROCHLORIDE
BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE
SYMPROIC, NALDEMEDINE TOSYLATE
BE PHARMS
* BE PHARMACEUTICALS AG
DAPTOMYCIN, DAPTOMYCIN
FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
BECTON DICKINSON
* BECTON DICKINSON AND CO
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
E-Z SCRUB 201, POVIDONE-IODINE (OTC)
E-Z SCRUB 241, POVIDONE-IODINE (OTC)
BECTON DICKINSON CO
* BECTON DICKINSON AND CO
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)
BEIGENE
* BEIGENE USA INC
BRUKINSA, ZANUBRUTINIB
BEIJING YILING
* BEIJING YILING BIO-ENGEERING AND TECHNOLOGY CO LTD
ANASTROZOLE, ANASTROZOLE
LETROZOLE, LETROZOLE
BELCHER PHARMS
* BELCHER PHARMACEUTICALS LLC
CEPHALEXIN, CEPHALEXIN
DESLORATADINE, DESLORATADINE
BELCHER PHARMS LLC
* BELCHER PHARMACEUTICALS LLC
ABLYSINOL, ALCOHOL
CEFIXIME, CEFIXIME
EPINEPHRINE, EPINEPHRINE
MEFENAMIC ACID, MEFENAMIC ACID
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 47

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BELCHER PHARMACEUTICALS LLC
TACROLIMUS, TACROLIMUS
BELOTECA INC
* BELOTECA INC
DIAZEPAM, DIAZEPAM
BEXIMCO PHARMS USA
* BEXIMCO PHARMACEUTICALS USA INC
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
LOVASTATIN, LOVASTATIN
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHOCARBAMOL, METHOCARBAMOL
NADOLOL, NADOLOL
RIBAVIRIN, RIBAVIRIN
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
BEXIMCO USA
* BEXIMCO PHARMACEUTICALS USA INC
CARVEDILOL, CARVEDILOL
BIOCODEX SA
* BIOCODEX SA
DIACOMIT, STIRIPENTOL
BIOCON LIMITED
* BIOCON LIMITED
SIMVASTATIN, SIMVASTATIN
BIOCON LTD
* BIOCON LTD
FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
BIOCRYST
* BIOCRYST PHARMACEUTICALS INC
RAPIVAB, PERAMIVIR
BIOFRONTERA
* BIOFRONTERA BIOSCIENCE GMBH
AMELUZ, AMINOLEVULINIC ACID HYDROCHLORIDE
BIOGEN
* BIOGEN
VUMERITY, DIROXIMEL FUMARATE
BIOGEN IDEC
* BIOGEN IDEC INC
SPINRAZA, NUSINERSEN SODIUM
BIOGEN IDEC INC
* BIOGEN IDEC INC
TECFIDERA, DIMETHYL FUMARATE
BIOMARIN PHARM
* BIOMARIN PHARMACEUTICAL INC
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
BIOMEDCL RES FDN
* BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
BIONPHARMA INC
* BIONPHARMA INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
BENZONATATE, BENZONATATE
BEXAROTENE, BEXAROTENE
CALCITRIOL, CALCITRIOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CLOBAZAM, CLOBAZAM
COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE
DEFERASIROX, DEFERASIROX
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 48

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BIONPHARMA INC
DOFETILIDE, DOFETILIDE
DUTASTERIDE, DUTASTERIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MIDOL LIQUID GELS, IBUPROFEN (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NIMODIPINE, NIMODIPINE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PARICALCITOL, PARICALCITOL
PROGESTERONE, PROGESTERONE
RUFINAMIDE, RUFINAMIDE
TETRABENAZINE, TETRABENAZINE
VALPROIC ACID, VALPROIC ACID
VITAMIN D, ERGOCALCIFEROL
ZONISAMIDE, ZONISAMIDE
BLAIREX
* BLAIREX LABORATORIES INC
BRONCHO SALINE, SODIUM CHLORIDE (OTC)
BLUE EARTH
* BLUE EARTH DIAGNOSTICS LTD
AXUMIN, FLUCICLOVINE F-18
BOEHRINGER INGELHEIM
* BOEHRINGER INGELHEIM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
GILOTRIF, AFATINIB DIMALEATE
GLYXAMBI, EMPAGLIFLOZIN
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC
AGGRENOX, ASPIRIN
APTIVUS, TIPRANAVIR
ATROVENT HFA, IPRATROPIUM BROMIDE
COMBIVENT RESPIMAT, ALBUTEROL SULFATE
JARDIANCE, EMPAGLIFLOZIN
JENTADUETO XR, LINAGLIPTIN
JENTADUETO, LINAGLIPTIN
MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE
MOBIC, MELOXICAM
OFEV, NINTEDANIB ESYLATE
PERSANTINE, DIPYRIDAMOLE
PRADAXA, DABIGATRAN ETEXILATE MESYLATE
SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE
SPIRIVA, TIOTROPIUM BROMIDE
STIOLTO RESPIMAT, OLODATEROL HYDROCHLORIDE
STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE
SYNJARDY XR, EMPAGLIFLOZIN
SYNJARDY, EMPAGLIFLOZIN
TRADJENTA, LINAGLIPTIN
TWYNSTA, AMLODIPINE BESYLATE
VIRAMUNE XR, NEVIRAPINE
VIRAMUNE, NEVIRAPINE
BOSCOGEN
* BOSCOGEN INC
ARIPIPRAZOLE, ARIPIPRAZOLE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 49

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BOSCOGEN INC
CAPTOPRIL, CAPTOPRIL
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
REPAGLINIDE, REPAGLINIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
BPI LABS LLC
* BPI LABS LLC
ZOLEDRONIC ACID, ZOLEDRONIC ACID
BRACCO
* BRACCO DIAGNOSTICS INC
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
E-Z-HD, BARIUM SULFATE
E-Z-PAQUE, BARIUM SULFATE
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
KINEVAC, SINCALIDE
LIQUID E-Z-PAQUE, BARIUM SULFATE
LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
PROHANCE MULTIPACK, GADOTERIDOL
PROHANCE, GADOTERIDOL
READI-CAT 2 SMOOTHIE, BARIUM SULFATE
READI-CAT 2, BARIUM SULFATE
TAGITOL V, BARIUM SULFATE
VARIBAR HONEY, BARIUM SULFATE
VARIBAR NECTAR, BARIUM SULFATE
VARIBAR PUDDING, BARIUM SULFATE
VARIBAR THIN HONEY, BARIUM SULFATE
VARIBAR THIN LIQUID, BARIUM SULFATE
BRAINTREE
* BRAINTREE LABORATORIES INC
GOLYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
BRAINTREE LABS
* BRAINTREE LABORATORIES INC
SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE
BRECKENRIDGE
* BRECKENRIDGE PHARMACEUTICAL INC
ALPRAZOLAM, ALPRAZOLAM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLOBAZAM, CLOBAZAM
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENTECAVIR, ENTECAVIR
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPLERENONE, EPLERENONE
EXEMESTANE, EXEMESTANE
IMATINIB MESYLATE, IMATINIB MESYLATE
LEVETIRACETAM, LEVETIRACETAM
MEGESTROL ACETATE, MEGESTROL ACETATE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
OMEPRAZOLE, OMEPRAZOLE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 50

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BRECKENRIDGE PHARMACEUTICAL INC
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIVASTIGMINE, RIVASTIGMINE
ROFLUMILAST, ROFLUMILAST
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
BRECKENRIDGE PHARM
* BRECKENRIDGE PHARMACEUTICAL INC
CILOSTAZOL, CILOSTAZOL
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
LEVETIRACETAM, LEVETIRACETAM
MELOXICAM, MELOXICAM
OXCARBAZEPINE, OXCARBAZEPINE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
BRIGHAM WOMENS
* BRIGHAM AND WOMENS HOSP
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
BRIGHAM WOMENS HOSP
* BRIGHAM AND WOMENS HOSP INC
AMMONIA N 13, AMMONIA N-13
BRIGHTGENE
* BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD
ENTECAVIR, ENTECAVIR
BRISTOL MYERS SQUIBB
* BRISTOL MYERS SQUIBB
AZACTAM, AZTREONAM
BARACLUDE, ENTECAVIR
PRAVACHOL, PRAVASTATIN SODIUM
* BRISTOL MYERS SQUIBB CO
DROXIA, HYDROXYUREA
HYDREA, HYDROXYUREA
REYATAZ, ATAZANAVIR SULFATE
SPRYCEL, DASATINIB
SUSTIVA, EFAVIRENZ
VIDEX EC, DIDANOSINE
* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ELIQUIS, APIXABAN
ZERIT, STAVUDINE
* BRISTOL MYERS SQUIBB PHARMA CO
COUMADIN, WARFARIN SODIUM
BRISTOL-MYERS SQUIBB
* BRISTOL-MYERS SQUIBB CO
EVOTAZ, ATAZANAVIR SULFATE
VIDEX, DIDANOSINE
BTCP PHARMA
* BTCP PHARMA LLC
LAZANDA, FENTANYL CITRATE
SUBSYS, FENTANYL
BWXT ITG
* BWXT ITG CANADA INC
INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
** C **
CADILA
* CADILA HEALTHCARE LTD
ACETAZOLAMIDE, ACETAZOLAMIDE
ACYCLOVIR, ACYCLOVIR
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
DESONIDE, DESONIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 51

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CADILA HEALTHCARE LTD
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DUTASTERIDE, DUTASTERIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FELBAMATE, FELBAMATE
INDOMETHACIN, INDOMETHACIN
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METRONIDAZOLE, METRONIDAZOLE
MODAFINIL, MODAFINIL
NYSTATIN, NYSTATIN
PIROXICAM, PIROXICAM
RANOLAZINE, RANOLAZINE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
CADILA PHARMS LTD
* CADILA PHARMACEUTICALS LTD
ACYCLOVIR, ACYCLOVIR
CELECOXIB, CELECOXIB
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
GEMFIBROZIL, GEMFIBROZIL
GLYBURIDE, GLYBURIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
METRONIDAZOLE, METRONIDAZOLE
NATEGLINIDE, NATEGLINIDE
OFLOXACIN, OFLOXACIN
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
TELMISARTAN, TELMISARTAN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
CADISTA PHARMS
* CADISTA PHARMACEUTICALS INC
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
CALL INC
* CALL INC DBA ROCHESTER PHARMACEUTICALS
ADAPALENE, ADAPALENE
CAPELLON PHARMS LLC
* CAPELLON PHARMACEUTICALS LLC
POLMON, DEXCHLORPHENIRAMINE MALEATE
CAPLIN
* CAPLIN STERILES LTD
GLYCOPYRROLATE, GLYCOPYRROLATE
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
CARDINAL HEALTH 414
* CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
CARDINAL HEALTH 418
* CARDINAL HEALTH 418 INC
SODIUM IODIDE I 123, SODIUM IODIDE I-123
CARIBE HOLDINGS
* CARIBE HOLDINGS CAYMAN CO LTD DBA PURACAP CARIBE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 52

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CARIBE HOLDINGS CAYMAN CO LTD DBA PURACAP CARIBE
GEMFIBROZIL, GEMFIBROZIL
CARLSBAD
* CARLSBAD TECHNOLOGY INC
ACYCLOVIR, ACYCLOVIR
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
FAMOTIDINE, FAMOTIDINE
GLIMEPIRIDE, GLIMEPIRIDE
LOVASTATIN, LOVASTATIN
CARLSBAD TECHNOLOGY
* CARLSBAD TECHNOLOGY INC
ACYCLOVIR, ACYCLOVIR
CASI PHARMS INC
* CASI PHARMACEUTICALS INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CEFPROZIL, CEFPROZIL
CILOSTAZOL, CILOSTAZOL
DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
ENTECAVIR, ENTECAVIR
HEPARIN SODIUM, HEPARIN SODIUM
LISINOPRIL, LISINOPRIL
METHIMAZOLE, METHIMAZOLE
NABUMETONE, NABUMETONE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
REPAGLINIDE, REPAGLINIDE
TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
CASPER PHARMA LLC
* CASPER PHARMA LLC
ANTIVERT, MECLIZINE HYDROCHLORIDE
AQUASOL A, VITAMIN A PALMITATE
CASPORYN HC, HYDROCORTISONE
FURADANTIN, NITROFURANTOIN
NEOSPORIN, BACITRACIN ZINC
ZYLOPRIM, ALLOPURINOL
CATALENT
* CATALENT PHARMA SOLUTIONS LLC
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
VALPROIC ACID, VALPROIC ACID
CATALYST PHARMS
* CATALYST PHARMACEUTICALS INC
FIRDAPSE, AMIFAMPRIDINE PHOSPHATE
CEDIPROF INC
* CEDIPROF INC
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
LEVO-T, LEVOTHYROXINE SODIUM **
CELATOR PHARMS
* CELATOR PHARMACEUTICALS INC
VYXEOS, CYTARABINE
CELGENE
* CELGENE CORP
ISTODAX, ROMIDEPSIN
POMALYST, POMALIDOMIDE
REVLIMID, LENALIDOMIDE
THALOMID, THALIDOMIDE
VIDAZA, AZACITIDINE
CELGENE CORP
* CELGENE CORP
IDHIFA, ENASIDENIB MESYLATE
CELLTRION
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 53

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CELLTRION INC
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FAMOTIDINE, FAMOTIDINE
LEVOFLOXACIN, LEVOFLOXACIN
LINEZOLID, LINEZOLID
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
TEMIXYS, LAMIVUDINE
ZONISAMIDE, ZONISAMIDE
CEPHALON
* CEPHALON INC
ACTIQ, FENTANYL CITRATE
FENTORA, FENTANYL CITRATE
GABITRIL, TIAGABINE HYDROCHLORIDE
NUVIGIL, ARMODAFINIL
PROVIGIL, MODAFINIL
TREANDA, BENDAMUSTINE HYDROCHLORIDE
TRISENOX, ARSENIC TRIOXIDE
CEYONE
* CEYONE PHARMA LLC
BUMETANIDE, BUMETANIDE
CHANGZHOU PHARM
* CHANGZHOU PHARMACEUTICAL FACTORY
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
CHARTWELL
* CHARTWELL LIFE MOLECULES LLC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLARITHROMYCIN, CLARITHROMYCIN
FLUCONAZOLE, FLUCONAZOLE
CHARTWELL LIFE SCI
* CHARTWELL LIFE SCIENCE LLC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
CHARTWELL MOLECULAR
* CHARTWELL MOLECULAR HOLDINGS LLC
CALCIUM ACETATE, CALCIUM ACETATE
CARVEDILOL, CARVEDILOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FOLIC ACID, FOLIC ACID
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRBESARTAN, IRBESARTAN
RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE
CHARTWELL MOLECULES
* CHARTWELL MOLECULES LLC
DISULFIRAM, DISULFIRAM
GEMFIBROZIL, GEMFIBROZIL
NABUMETONE, NABUMETONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
CHARTWELL RX
* CHARTWELL RX SCIENCES LLC
CALCIUM ACETATE, CALCIUM ACETATE
CILOSTAZOL, CILOSTAZOL
DUVOID, BETHANECHOL CHLORIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
INDOMETHACIN, INDOMETHACIN
LEVETIRACETAM, LEVETIRACETAM
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 54

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CHARTWELL RX SCIENCES LLC
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
CHARTWELL TETRA
* CHARTWELL TETRA LLC
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
CHATTEM
* CHATTEM INC
UNISOM, DOXYLAMINE SUCCINATE (OTC)
CHEMI SPA
* CHEMI SPA
DECITABINE, DECITABINE
TEMOZOLOMIDE, TEMOZOLOMIDE
CHEMISCH FBRK KRSSLR
* CHEMISCHE FABRIK KREUSSLER & CO. GMBH
ASCLERA, POLIDOCANOL
CHEMO RESEARCH SL
* CHEMO RESEARCH SL
BENZNIDAZOLE, BENZNIDAZOLE
NUVESSA, METRONIDAZOLE
CHEPLAPHARM
* CHEPLAPHARM ARZNEIMITTEL GMBH
CYTOVENE, GANCICLOVIR SODIUM
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
XENICAL, ORLISTAT
CHIESI USA INC
* CHIESI USA INC
BETHKIS, TOBRAMYCIN
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CLEVIPREX, CLEVIDIPINE
CUROSURF, PORACTANT ALFA
KENGREAL, CANGRELOR
ZYFLO CR, ZILEUTON
ZYFLO, ZILEUTON
CHILDRENS HOSP MI
* CHILDRENS HOSP MICHIGAN
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
CHINA RESOURCES
* CHINA RESOURCES SAIKE PHARMACEUTICAL CO LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CHIRHOCLIN
* CHIRHOCLIN INC
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CINTEX SVCS
* CINTEX SERVICES LLC
FLURANDRENOLIDE, FLURANDRENOLIDE
CIPHER PHARMS INC
* CIPHER PHARMACEUTICALS INC
CONZIP, TRAMADOL HYDROCHLORIDE
LIPOFEN, FENOFIBRATE
CIPLA
* CIPLA LTD
ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE
ABACAVIR SULFATE, ABACAVIR SULFATE
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMBRISENTAN, AMBRISENTAN
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATAZANAVIR SULFATE, ATAZANAVIR SULFATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 55

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CIPLA LTD
AZACITIDINE, AZACITIDINE
BIVALIRUDIN, BIVALIRUDIN
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BOSENTAN, BOSENTAN
BUDESONIDE, BUDESONIDE
CELECOXIB, CELECOXIB
CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
DECITABINE, DECITABINE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
EFAVIRENZ, EFAVIRENZ
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ
EMTRICITABINE, EMTRICITABINE
ENTECAVIR, ENTECAVIR
EXEMESTANE, EXEMESTANE
FAMCICLOVIR, FAMCICLOVIR
FENOFIBRATE, FENOFIBRATE
FINASTERIDE, FINASTERIDE
FLUTAMIDE, FLUTAMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
MELOXICAM, MELOXICAM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NEVIRAPINE, NEVIRAPINE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREGABALIN, PREGABALIN
RANOLAZINE, RANOLAZINE
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
TADALAFIL, TADALAFIL
TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE, TESTOSTERONE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
ZIDOVUDINE, ZIDOVUDINE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
CIPLA LTD
* CIPLA LTD
ALBENDAZOLE, ALBENDAZOLE
CARBOPLATIN, CARBOPLATIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CIPLA USA
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 56

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CIPLA USA INC
ZEMDRI, PLAZOMICIN SULFATE
CIRCASSIA
* CIRCASSIA LTD
DUAKLIR PRESSAIR, ACLIDINIUM BROMIDE
TUDORZA PRESSAIR, ACLIDINIUM BROMIDE
CLARUS
* CLARUS THERAPEUTICS INC
JATENZO, TESTOSTERONE UNDECANOATE
CLINIGEN
* CLINIGEN INC
ETHYOL, AMIFOSTINE
TOTECT, DEXRAZOXANE HYDROCHLORIDE
CLINIGEN HLTHCARE
* CLINIGEN HEALTHCARE LTD
FOSCAVIR, FOSCARNET SODIUM
CLIVUNEL INC
* CLINUVEL INC
SCENESSE, AFAMELANOTIDE
CLOVER PHARMS
* CLOVER PHARMACEUTICALS CORP
AMICAR, AMINOCAPROIC ACID
CLOVIS ONCOLOGY INC
* CLOVIS ONCOLOGY INC
RUBRACA, RUCAPARIB CAMSYLATE
CMP DEV LLC
* CMP DEVELOPMENT LLC
CAROSPIR, SPIRONOLACTONE
POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC
CMP PHARMA INC
* CMP PHARMA INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE
ISONIAZID, ISONIAZID
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
SPS, SODIUM POLYSTYRENE SULFONATE
TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE
CNTY LINE PHARMS
* COUNTY LINE PHARMACEUTICALS LLC
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CICLOPIROX, CICLOPIROX
DYNACIN, MINOCYCLINE HYDROCHLORIDE
FLUOCINONIDE, FLUOCINONIDE
LIDEX, FLUOCINONIDE
LIDEX-E, FLUOCINONIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
TAMBOCOR, FLECAINIDE ACETATE
TRANDATE, LABETALOL HYDROCHLORIDE
TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE
UREX, METHENAMINE HIPPURATE
COEPTIS
* COEPTIS PHARMACEUTICALS INC
CONSENSI, AMLODIPINE BESYLATE
COLGATE PALMOLIVE CO
* COLGATE PALMOLIVE CO
PERIOGARD, CHLORHEXIDINE GLUCONATE
COLGATE-PALMOLIVE CO
* COLGATE-PALMOLIVE CO
PERIOGARD, CHLORHEXIDINE GLUCONATE
COLLEGIUM PHARM INC
* COLLEGIUM PHARMACEUTICAL INC
XTAMPZA ER, OXYCODONE
COMBE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 57

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* COMBE INC
VAGISTAT-1, TIOCONAZOLE (OTC)
CONCORD BIOTECH LTD
* CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
CONCORDIA
* CONCORDIA PHARMACEUTICALS INC
DUTOPROL, HYDROCHLOROTHIAZIDE
DYRENIUM, TRIAMTERENE
LANOXIN, DIGOXIN
NILANDRON, NILUTAMIDE
PANRETIN, ALITRETINOIN
PARNATE, TRANYLCYPROMINE SULFATE
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
SALAGEN, PILOCARPINE HYDROCHLORIDE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
CONCORDIA PHARMS INC
* CONCORDIA PHARMACEUTICALS INC
KAPVAY, CLONIDINE HYDROCHLORIDE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
CONTRACT PHARMACAL
* CONTRACT PHARMACAL CORP
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
COOPERSURGICAL
* COOPERSURGICAL INC
PARAGARD T 380A, COPPER
CORCEPT THERAP
* CORCEPT THERAPEUTICS INC
KORLYM, MIFEPRISTONE
CORDEN PHARMA
* CORDEN PHARMA LATINA SPA
GLEOSTINE, LOMUSTINE
COSETTE
* COSETTE PHARMACEUTICALS INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
MIGERGOT, CAFFEINE
COVIS PHARMA BV
* COVIS PHARMA BV
ALTOPREV, LOVASTATIN
ALVESCO, CICLESONIDE
BETAPACE AF, SOTALOL HYDROCHLORIDE
BETAPACE, SOTALOL HYDROCHLORIDE
LANOXIN PEDIATRIC, DIGOXIN
LANOXIN, DIGOXIN
OMNARIS, CICLESONIDE
PRILOSEC, OMEPRAZOLE MAGNESIUM
RILUTEK, RILUZOLE
SULAR, NISOLDIPINE
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ZETONNA, CICLESONIDE
CPDC
* CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
CPPI CV
* CP PHARMACEUTICALS INTERNATIONAL CV
SUTENT, SUNITINIB MALATE
CROSSMEDIKA SA
* CROSSMEDIKA SA
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 58

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
* CROSSMEDIKA SA
VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE
CROWN LABS
* CROWN LABORATORIES INC
ALA-CORT, HYDROCORTISONE
TRIDERM, TRIAMCINOLONE ACETONIDE
CROWN LABS INC
* CROWN LABORATORIES INC
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
CSPC OUYI
* CSPC OUYI PHARMACEUTICAL CO LTD
AZITHROMYCIN, AZITHROMYCIN
BENZONATATE, BENZONATATE
CELECOXIB, CELECOXIB
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CONJUPRI, LEVAMLODIPINE MALEATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PREGABALIN, PREGABALIN
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
CSPC OUYI PHARM CO
* CSPC OUYI PHARMACEUTICAL CO LTD
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
CUBIST PHARMS
* CUBIST PHARMACEUTICALS INC
ENTEREG, ALVIMOPAN
CUBIST PHARMS LLC
* CUBIST PHARMACEUTICALS LLC
CUBICIN RF, DAPTOMYCIN
CUBICIN, DAPTOMYCIN
DIFICID, FIDAXOMICIN
SIVEXTRO, TEDIZOLID PHOSPHATE
ZERBAXA, CEFTOLOZANE SULFATE
CUMBERLAND PHARMS
* CUMBERLAND PHARMACEUTICALS INC
ACETADOTE, ACETYLCYSTEINE
CALDOLOR, IBUPROFEN
LACTULOSE, LACTULOSE
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN
REDITREX, METHOTREXATE
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
VIBATIV, TELAVANCIN HYDROCHLORIDE
CURIUM
* CURIUM US LLC
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
XENON XE 133, XENON XE-133
CURRAX
* CURRAX PHARMACEUTICALS LLC
ONZETRA XSAIL, SUMATRIPTAN SUCCINATE
SILENOR, DOXEPIN HYDROCHLORIDE
TREXIMET, NAPROXEN SODIUM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 59

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **
CUSTOPHARM INC
* CUSTOPHARM INC
ACETAMINOPHEN, ACETAMINOPHEN
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM
SODIUM TETRADECYL SULFATE, SODIUM TETRADECYL SULFATE
VALRUBICIN, VALRUBICIN
CYCLE PHARMS LTD
* CYCLE PHARMACEUTICALS LTD
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
NITYR, NITISINONE
** D **
DAEWOONG PHARM CO
* DAEWOONG PHARMACEUTICAL CO LTD
MEROPENEM, MEROPENEM
DAIICHI SANKYO
* DAIICHI SANKYO INC
AZOR, AMLODIPINE BESYLATE
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENICAR, OLMESARTAN MEDOXOMIL
TRIBENZOR, AMLODIPINE BESYLATE
WELCHOL, COLESEVELAM HYDROCHLORIDE
DAIICHI SANKYO INC
* DAIICHI SANKYO INC
EVOXAC, CEVIMELINE HYDROCHLORIDE
MORPHABOND ER, MORPHINE SULFATE
SAVAYSA, EDOXABAN TOSYLATE
TURALIO, PEXIDARTINIB HYDROCHLORIDE
WELCHOL, COLESEVELAM HYDROCHLORIDE
DANCO LABS LLC
* DANCO LABORATORIES LLC
MIFEPREX, MIFEPRISTONE
DAVA INTL INC
* DAVA INTERNATIONAL INC
ALPRAZOLAM, ALPRAZOLAM
DAVA PHARMS INC
* DAVA PHARMACEUTICALS INC
ACYCLOVIR, ACYCLOVIR
AMOXICILLIN, AMOXICILLIN
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ATENOLOL, ATENOLOL
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
GLYBURIDE (MICRONIZED), GLYBURIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PROPYLTHIOURACIL, PROPYLTHIOURACIL
PYRAZINAMIDE, PYRAZINAMIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
VOSPIRE ER, ALBUTEROL SULFATE
DAVIS AND GECK
* DAVIS AND GECK DIV AMERICAN CYANAMID CO
PRE-OP II, HEXACHLOROPHENE
PRE-OP, HEXACHLOROPHENE
DBL PHARMS
* DBL PHARMACEUTICALS INC
METHOCARBAMOL, METHOCARBAMOL
DECATUR
* DECATUR MEMORIAL HOSP
AMMONIA N 13, AMMONIA N-13
CHOLINE C-11, CHOLINE C-11
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 60

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **
* DECATUR MEMORIAL HOSP
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
DENTSPLY PHARM
* DENTSPLY PHARMACEUTICAL INC
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
ORAQIX, LIDOCAINE
DEPO NF
* DEPO NF SUB LLC A SUB OF ASSERTIO THERAPEUTICS INC
NUCYNTA ER, TAPENTADOL HYDROCHLORIDE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
DEPROCO
* DEPROCO INC
LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE
LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE
SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
DERMIRA INC
* DERMIRA INC
QBREXZA, GLYCOPYRRONIUM TOSYLATE
DEVA HOLDING AS
* DEVA HOLDING AS
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
TEMOZOLOMIDE, TEMOZOLOMIDE
DEXCEL LTD
* DEXCEL LTD
DICLOFENAC SODIUM, DICLOFENAC SODIUM
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
DEXCEL PHARMA
* DEXCEL PHARMA TECHNOLOGIES LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
HEMADY, DEXAMETHASONE
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
LEVETIRACETAM, LEVETIRACETAM
OMEPRAZOLE, OMEPRAZOLE (OTC)
PERIOCHIP, CHLORHEXIDINE GLUCONATE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
DFB ONCOLOGY LTD
* DFB ONCOLOGY LTD
DOCETAXEL, DOCETAXEL
DIAGNOSTIC GREEN
* DIAGNOSTIC GREEN GMBH
INDOCYANINE GREEN, INDOCYANINE GREEN
DIALYSIS SUPS
* DIALYSIS SUPPLIES INC
NORMOCARB HF 25, MAGNESIUM CHLORIDE
NORMOCARB HF 35, MAGNESIUM CHLORIDE
DIGESTIVE CARE INC
* DIGESTIVE CARE INC
PERTZYE, PANCRELIPASE (AMYLASE
DORC
* DORC INTERNATIONAL BV
MEMBRANEBLUE, TRYPAN BLUE
VISIONBLUE, TRYPAN BLUE
DOUGLAS PHARMS
* DOUGLAS PHARMACEUTICALS AMERICA LTD
MYORISAN, ISOTRETINOIN
DOW PHARM
* DOW PHARMACEUTICAL SCIENCES
ALTRENO, TRETINOIN
ATRALIN, TRETINOIN
DR REDDYS
* DR REDDYS LABORATORIES INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 61

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **
* DR REDDYS LABORATORIES INC
NITROGLYCERIN, NITROGLYCERIN
PROGESTERONE, PROGESTERONE
PROPOFOL, PROPOFOL
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TESTOSTERONE, TESTOSTERONE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* DR REDDYS LABORATORIES LTD
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
AZACITIDINE, AZACITIDINE
CARFILZOMIB, CARFILZOMIB
COLCHICINE, COLCHICINE
COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE
DAPTOMYCIN, DAPTOMYCIN
DECITABINE, DECITABINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IMATINIB MESYLATE, IMATINIB MESYLATE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
OMEPRAZOLE, OMEPRAZOLE (OTC)
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PARICALCITOL, PARICALCITOL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PREGABALIN, PREGABALIN
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE
TETRABENAZINE, TETRABENAZINE
THIOTEPA, THIOTEPA
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
DR REDDYS LA
* DR REDDYS LABORATORIES LOUISIANA LLC
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LOPURIN, ALLOPURINOL
SSD, SILVER SULFADIAZINE
DR REDDYS LABS INC
* DR REDDYS LABORATORIES INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LEVOFLOXACIN, LEVOFLOXACIN
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SIMVASTATIN, SIMVASTATIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
DR REDDYS LABS LTD
* DR REDDYS LABORATORIES LIMITED
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* DR REDDYS LABORATORIES LTD
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 62

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **
* DR REDDYS LABORATORIES LTD
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
BIVALIRUDIN, BIVALIRUDIN
BORTEZOMIB, BORTEZOMIB
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLOFARABINE, CLOFARABINE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOCETAXEL, DOCETAXEL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)
ESZOPICLONE, ESZOPICLONE
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FESOTERODINE FUMARATE, FESOTERODINE FUMARATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
NATEGLINIDE, NATEGLINIDE
NIZATIDINE, NIZATIDINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 63

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **
* DR REDDYS LABORATORIES LTD
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXAPROZIN, OXAPROZIN
PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PARICALCITOL, PARICALCITOL
PHYTONADIONE, PHYTONADIONE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SEVELAMER CARBONATE, SEVELAMER CARBONATE
SIROLIMUS, SIROLIMUS
SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE
TACROLIMUS, TACROLIMUS
TADALAFIL, TADALAFIL
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VIGABATRIN, VIGABATRIN
ZAFIRLUKAST, ZAFIRLUKAST
ZENATANE, ISOTRETINOIN
ZOLEDRONIC ACID, ZOLEDRONIC ACID
DR REDDYS LABS SA
* DR REDDYS LABORATORIES SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
EZETIMIBE AND SIMVASTATIN, EZETIMIBE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
HABITROL, NICOTINE (OTC)
MERCAPTOPURINE, MERCAPTOPURINE
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
RAMELTEON, RAMELTEON
TOBRAMYCIN, TOBRAMYCIN
DRAXIMAGE
* DRAXIMAGE INC
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
DUCHESNAY
* DUCHESNAY INC
BONJESTA, DOXYLAMINE SUCCINATE
DICLEGIS, DOXYLAMINE SUCCINATE
OSPHENA, OSPEMIFENE
DURAMED PHARMS BARR
* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AVIANE-28, ETHINYL ESTRADIOL
CRYSELLE, ETHINYL ESTRADIOL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
ENPRESSE-28, ETHINYL ESTRADIOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VELIVET, DESOGESTREL
DUSA
* DUSA PHARMACEUTICALS INC
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
DUTCH OPHTHALMIC
* DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
TISSUEBLUE, BRILLIANT BLUE G
REDDYS
* DOCTOR REDDYS LABORATORIES LTD
DESLORATADINE, DESLORATADINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 64

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **
* DOCTOR REDDYS LABORATORIES LTD
DIVALPROEX SODIUM, DIVALPROEX SODIUM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
** E **
E5 PHARMA INC
* E5 PHARMA INC
DIAZOXIDE, DIAZOXIDE
EAGLE PHARMS
* EAGLE PHARMACEUTICALS INC
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
BELRAPZO, BENDAMUSTINE HYDROCHLORIDE
BENDEKA, BENDAMUSTINE HYDROCHLORIDE
RYANODEX, DANTROLENE SODIUM
ECI PHARMS LLC
* ECI PHARMACEUTICALS LLC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LAMIVUDINE, LAMIVUDINE
LEVETIRACETAM, LEVETIRACETAM
METHIMAZOLE, METHIMAZOLE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
VALPROIC ACID, VALPROIC ACID
ECOLAB
* ECOLAB INC
CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)
CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)
ECR
* ECR PHARMACEUTICALS
DEXAMETHASONE, DEXAMETHASONE
ECR PHARMA
* ECR PHARMA
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
EDENBRIDGE PHARMS
* EDENBRIDGE PHARMACEUTICALS LLC
ALBENDAZOLE, ALBENDAZOLE
CARBIDOPA, CARBIDOPA
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
ETHACRYNIC ACID, ETHACRYNIC ACID
ETODOLAC, ETODOLAC
IVERMECTIN, IVERMECTIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
TINIDAZOLE, TINIDAZOLE
EDISON THERAPS LLC
* EDISON THERAPEUTICS LLC
METHERGINE, METHYLERGONOVINE MALEATE
EGALET
* EGALET US INC
INDOCIN, INDOMETHACIN
EI INC
* EI INC
THEROXIDIL, MINOXIDIL (OTC)
EISAI INC
* EISAI INC
ACIPHEX, RABEPRAZOLE SODIUM
ARICEPT, DONEPEZIL HYDROCHLORIDE
BANZEL, RUFINAMIDE
BELVIQ XR, LORCASERIN HYDROCHLORIDE
BELVIQ, LORCASERIN HYDROCHLORIDE
FYCOMPA, PERAMPANEL
HALAVEN, ERIBULIN MESYLATE
LENVIMA, LENVATINIB MESYLATE
ELI LILLY AND CO
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 65

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **
* ELI LILLY AND CO
BAQSIMI, GLUCAGON
BASAGLAR, INSULIN GLARGINE
EFFIENT, PRASUGREL HYDROCHLORIDE
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
OLUMIANT, BARICITINIB
PROZAC, FLUOXETINE HYDROCHLORIDE
VERZENIO, ABEMACICLIB
ELI LILLY CO
* ELI LILLY CO
ADCIRCA, TADALAFIL
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ELITE LABS
* ELITE LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
ELITE LABS INC
* ELITE LABORATORIES INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
DANTROLENE SODIUM, DANTROLENE SODIUM
ISRADIPINE, ISRADIPINE
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
ELYSIUM
* ELYSIUM PHARMACEUTICALS LTD
CALCITRIOL, CALCITRIOL
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
EMCURE PHARMS
* EMCURE PHARMACEUTICALS LTD
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
EMCURE PHARMS LTD
* EMCURE PHARMACEUTICALS LTD
ACARBOSE, ACARBOSE
AMIKACIN SULFATE, AMIKACIN SULFATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BICNU, CARMUSTINE
CIDOFOVIR, CIDOFOVIR
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ETOMIDATE, ETOMIDATE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FUROSEMIDE, FUROSEMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
RIFAMPIN, RIFAMPIN
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
TRANEXAMIC ACID, TRANEXAMIC ACID
ZOLEDRONIC ACID, ZOLEDRONIC ACID
EMD SERONO
* EMD SERONO INC
GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
OVIDREL, CHORIOGONADOTROPIN ALFA
SAIZEN, SOMATROPIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 66

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **
* EMD SERONO INC
SEROSTIM, SOMATROPIN
ZORBTIVE, SOMATROPIN RECOMBINANT
EMD SERONO INC
* EMD SERONO INC
CETROTIDE, CETRORELIX
MAVENCLAD, CLADRIBINE
EMERALD INTL LTD
* EMERALD INTERNATIONAL LTD
BACLOFEN, BACLOFEN
EMMAUS MEDCL
* EMMAUS MEDICAL INC
ENDARI, L-GLUTAMINE
ENCORE DERMAT
* ENCORE DERMATOLOGY INC
IMPOYZ, CLOBETASOL PROPIONATE
SERNIVO, BETAMETHASONE DIPROPIONATE
ENCUBE
* ENCUBE ETHICALS PRIVATE LTD
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
ENCUBE ETHICALS
* ENCUBE ETHICALS PVT LTD
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DESONIDE, DESONIDE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
PERMETHRIN, PERMETHRIN
ENDO PHARM
* ENDO PHARMACEUTICAL SOLUTIONS INC
SUPPRELIN LA, HISTRELIN ACETATE
VALSTAR PRESERVATIVE FREE, VALRUBICIN
VANTAS, HISTRELIN ACETATE
ENDO PHARMS
* ENDO PHARMACEUTICALS INC
FORTESTA, TESTOSTERONE
FROVA, FROVATRIPTAN SUCCINATE
PERCODAN, ASPIRIN
ENDO PHARMS INC
* ENDO PHARMACEUTICALS INC
AVEED, TESTOSTERONE UNDECANOATE
COLY-MYCIN S, COLISTIN SULFATE
MEGACE ES, MEGESTROL ACETATE
NASCOBAL, CYANOCOBALAMIN
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
EPI HLTH
* EPI HEALTH LLC
CLODERM, CLOCORTOLONE PIVALATE
MINOLIRA, MINOCYCLINE HYDROCHLORIDE
RHOFADE, OXYMETAZOLINE HYDROCHLORIDE
SITAVIG, ACYCLOVIR
EPIC PHARMA
* EPIC PHARMA INC
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
* EPIC PHARMA LLC
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
SULINDAC, SULINDAC
TRANDOLAPRIL, TRANDOLAPRIL
URSODIOL, URSODIOL
EPIC PHARMA INC
* EPIC PHARMA INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 67

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **
* EPIC PHARMA INC
ESTRADIOL, ESTRADIOL
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
EPIC PHARMA LLC
* EPIC PHARMA LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AZITHROMYCIN, AZITHROMYCIN
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
GABAPENTIN, GABAPENTIN
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE, GLYBURIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
MOLINDONE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PHENYTOIN, PHENYTOIN
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
ESPERO
* ESPERO BIOPHARMA INC
DURLAZA, ASPIRIN
ESSENTIAL ISOTOPES
* ESSENTIAL ISOTOPES LLC
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
ETHYPHARM
* ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
ETHYPHARM USA CORP
* ETHYPHARM USA CORP
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
ETON PHARMS
* ETON PHARMACEUTICALS
BIORPHEN, PHENYLEPHRINE HYDROCHLORIDE
EUGIA PHARMA
* EUGIA PHARMA SPECIALITIES LTD
CAPECITABINE, CAPECITABINE
CARBOPLATIN, CARBOPLATIN
HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE
LETROZOLE, LETROZOLE
OXALIPLATIN, OXALIPLATIN
PROGESTERONE, PROGESTERONE
EUROHLTH INTL SARL
* EUROHEALTH INTERNATIONAL SARL
DROPERIDOL, DROPERIDOL
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
EVUS
* EVUS HEALTH SOLUTIONS LLC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 68

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **
* EVUS HEALTH SOLUTIONS LLC
NITROMIST, NITROGLYCERIN
EXALENZ BIOSCIENCE
* EXALENZ BIOSCIENCE LTD
IDKIT:HP, CITRIC ACID
EXELA PHARMA SCIENCE
* EXELA PHARMA SCIENCES
CAFFEINE CITRATE, CAFFEINE CITRATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
EXELA PHARMA SCS LLC
* EXELA PHARMA SCIENCES LLC
CAFFEINE CITRATE, CAFFEINE CITRATE
ELCYS, CYSTEINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
GANZYK-RTU, GANCICLOVIR
GLYRX-PF, GLYCOPYRROLATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, SODIUM NITROPRUSSIDE
POTASSIUM ACETATE, POTASSIUM ACETATE
SODIUM BICARBONATE, SODIUM BICARBONATE
TRANEXAMIC ACID, TRANEXAMIC ACID
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
EXELIXIS
* EXELIXIS INC
COMETRIQ, CABOZANTINIB S-MALATE
EXELIXIS INC
* EXELIXIS INC
CABOMETYX, CABOZANTINIB S-MALATE
EXELTIS USA INC
* EXELTIS USA INC
SLYND, DROSPIRENONE
EYEPOINT PHARMS
* EYEPOINT PHARMACEUTICALS INC
DEXYCU KIT, DEXAMETHASONE
YUTIQ, FLUOCINOLONE ACETONIDE
EYEVANCE
* EYEVANCE PHARMACEUTICALS LLC
FLAREX, FLUOROMETHOLONE ACETATE
ZERVIATE, CETIRIZINE HYDROCHLORIDE
EYWA
* EYWA PHARMA INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
EYWA PHARMA
* EYWA PHARMA PTE LTD
ACETAZOLAMIDE, ACETAZOLAMIDE
ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE
BACLOFEN, BACLOFEN
URSODIOL, URSODIOL
LILLY
* ELI LILLY AND CO
ALIMTA, PEMETREXED DISODIUM
CIALIS, TADALAFIL
CYMBALTA, DULOXETINE HYDROCHLORIDE
EVISTA, RALOXIFENE HYDROCHLORIDE
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
GEMZAR, GEMCITABINE HYDROCHLORIDE
GLUCAGON, GLUCAGON
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG TEMPO PEN, INSULIN LISPRO RECOMBINANT
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 69

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **
* ELI LILLY AND CO
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R KWIKPEN, INSULIN HUMAN
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN HUMAN
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
STRATTERA, ATOMOXETINE HYDROCHLORIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
ZYPREXA ZYDIS, OLANZAPINE
ZYPREXA, OLANZAPINE
** F **
FDC LTD
* FDC LTD
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
LATANOPROST, LATANOPROST
OFLOXACIN, OFLOXACIN
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
FDN CONSUMER
* FOUNDATION CONSUMER HEALTHCARE LLC
PLAN B ONE-STEP, LEVONORGESTREL (OTC)
FEINSTEIN
* FEINSTEIN INSTITUTE MEDICAL RESEARCH
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FLUORODOPA F18, FLUORODOPA F-18
FERA PHARMS
* FERA PHARMACEUTICALS LLC
TOBRAMYCIN, TOBRAMYCIN
FERA PHARMS LLC
* FERA PHARMACEUTICALS LLC
DEXAMETHASONE, DEXAMETHASONE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
FERRER INTERNACIONAL
* FERRER INTERNACIONAL SA
XEPI, OZENOXACIN
FERRING
* FERRING PHARMACEUTICALS INC
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
ENDOMETRIN, PROGESTERONE
FIRMAGON, DEGARELIX ACETATE
MENOPUR, MENOTROPINS (FSH
MINIRIN, DESMOPRESSIN ACETATE
ZOMACTON, SOMATROPIN
FERRING PHARMS INC
* FERRING PHARMACEUTICALS INC
CERVIDIL, DINOPROSTONE
CLENPIQ, CITRIC ACID
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DDAVP, DESMOPRESSIN ACETATE
LYSTEDA, TRANEXAMIC ACID
NOCDURNA, DESMOPRESSIN ACETATE
STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
FLAMINGO PHARMS
* FLAMINGO PHARMACEUTICALS LTD
METRONIDAZOLE, METRONIDAZOLE
PIROXICAM, PIROXICAM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 70

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **
FLEXION THERAPS INC
* FLEXION THERAPEUTICS INC
ZILRETTA, TRIAMCINOLONE ACETONIDE
FOAMIX
* FOAMIX PHARMACEUTICALS INC
AMZEEQ, MINOCYCLINE HYDROCHLORIDE
FOLDRX PHARMS
* FOLDRX PHARMACEUTICALS INC SUB PFIZER INC
VYNDAMAX, TAFAMIDIS
VYNDAQEL, TAFAMIDIS MEGLUMINE
FOREST LABS LLC
* FOREST LABORATORIES LLC
NAMENDA XR, MEMANTINE HYDROCHLORIDE
FORTOVIA
* FORTOVIA THERAPEUTICS INC
ORAVIG, MICONAZOLE
SOLTAMOX, TAMOXIFEN CITRATE
FOSUN PHARMA
* FOSUN PHARMA USA INC
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
FOUGERA PHARMS
* FOUGERA PHARMACEUTICALS INC
ADAPALENE, ADAPALENE
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMCINONIDE, AMCINONIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CUTIVATE, FLUTICASONE PROPIONATE
DESONIDE, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ERYTHROMYCIN, ERYTHROMYCIN
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HYDROCORTISONE, HYDROCORTISONE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
LIDOCAINE AND PRILOCAINE, LIDOCAINE
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN, NYSTATIN
OXISTAT, OXICONAZOLE NITRATE
PANDEL, HYDROCORTISONE PROBUTATE
PREDNICARBATE, PREDNICARBATE
SOLARAZE, DICLOFENAC SODIUM
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERCONAZOLE, TERCONAZOLE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE
FOUGERA PHARMS INC
* FOUGERA PHARMACEUTICALS INC
ACYCLOVIR, ACYCLOVIR
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 71

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **
* FOUGERA PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE, LIDOCAINE
NITROGLYCERIN, NITROGLYCERIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
TACROLIMUS, TACROLIMUS
TERCONAZOLE, TERCONAZOLE
VEREGEN, SINECATECHINS
FRESENIUS
* FRESENIUS KABI DEUTSCHLAND GMBH
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
* FRESENIUS KABI IPSUM SRL
NAFCILLIN SODIUM, NAFCILLIN SODIUM
FRESENIUS KABI
* FRESENIUS KABI ANTI INFECTIVES SRL
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
* FRESENIUS KABI AUSTRIA GMBH
LACTULOSE, LACTULOSE
FRESENIUS KABI USA
* FRESENIUS KABI USA LLC
ACETAMINOPHEN, ACETAMINOPHEN
ACETYLCYSTEINE, ACETYLCYSTEINE
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
AMIKACIN SULFATE, AMIKACIN SULFATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANASTROZOLE, ANASTROZOLE
ARGATROBAN, ARGATROBAN
ARSENIC TRIOXIDE, ARSENIC TRIOXIDE
ATROPINE SULFATE, ATROPINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
AZTREONAM, AZTREONAM
BACITRACIN, BACITRACIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BIVALIRUDIN, BIVALIRUDIN
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BORTEZOMIB, BORTEZOMIB
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCIUM GLUCONATE, CALCIUM GLUCONATE
CARBOPLATIN, CARBOPLATIN
CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE
CEFOTETAN, CEFOTETAN DISODIUM
CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE
CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE
CISPLATIN, CISPLATIN
CLADRIBINE, CLADRIBINE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DAPTOMYCIN, DAPTOMYCIN
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 72

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **
* FRESENIUS KABI USA LLC
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILAUDID, HYDROMORPHONE HYDROCHLORIDE
DIMENHYDRINATE, DIMENHYDRINATE
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPRIVAN, PROPOFOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXY 100, DOXYCYCLINE HYCLATE
DOXY 200, DOXYCYCLINE HYCLATE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ETOPOSIDE, ETOPOSIDE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FLOXURIDINE, FLOXURIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUMAZENIL, FLUMAZENIL
FLUOROURACIL, FLUOROURACIL
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FULVESTRANT, FULVESTRANT
FUROSEMIDE, FUROSEMIDE
GANCICLOVIR SODIUM, GANCICLOVIR SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GLUCAGON, GLUCAGON HYDROCHLORIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
INDOMETHACIN, INDOMETHACIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LINEZOLID, LINEZOLID
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 73

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **
* FRESENIUS KABI USA LLC
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MANNITOL 25%, MANNITOL
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MESNA, MESNA
METHOCARBAMOL, METHOCARBAMOL
METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MICAFUNGIN SODIUM, MICAFUNGIN SODIUM
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NAROPIN, ROPIVACAINE HYDROCHLORIDE
NEBUPENT, PENTAMIDINE ISETHIONATE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
NESACAINE, CHLOROPROCAINE HYDROCHLORIDE
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OMEGAVEN, FISH OIL TRIGLYCERIDES
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
OXYTOCIN, OXYTOCIN
PACLITAXEL, PACLITAXEL
PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PENTAM, PENTAMIDINE ISETHIONATE
PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
POLOCAINE, MEPIVACAINE HYDROCHLORIDE
POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTAMINE SULFATE, PROTAMINE SULFATE
PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE
REMIFENTANIL HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SMOFLIPID 20%, FISH OIL
SODIUM ACETATE, SODIUM ACETATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
TIGECYCLINE, TIGECYCLINE
TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 74

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **
* FRESENIUS KABI USA LLC
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
VALPROATE SODIUM, VALPROATE SODIUM
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VIBISONE, CYANOCOBALAMIN
VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
FRESENIUS MEDCL
* FRESENIUS MEDICAL CARE NORTH AMERICA
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
PHOSLO GELCAPS, CALCIUM ACETATE
PHOSLYRA, CALCIUM ACETATE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
FRONTIDA BIOPHARM
* FRONTIDA BIOPHARM INC
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
** G **
G AND W LABS INC
* G AND W LABORATORIES INC
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GALDERMA LABS
* GALDERMA LABORATORIES INC
CLOBEX, CLOBETASOL PROPIONATE
EPIDUO FORTE, ADAPALENE
GALDERMA LABS LP
* GALDERMA LABORATORIES L P
CLOBEX, CLOBETASOL PROPIONATE
* GALDERMA LABORATORIES LP
CAPEX, FLUOCINOLONE ACETONIDE
CLOBEX, CLOBETASOL PROPIONATE
DESOWEN, DESONIDE
DIFFERIN, ADAPALENE
DIFFERIN, ADAPALENE (OTC)
EPIDUO, ADAPALENE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
MIRVASO, BRIMONIDINE TARTRATE
ORACEA, DOXYCYCLINE
SOOLANTRA, IVERMECTIN
TRI-LUMA, FLUOCINOLONE ACETONIDE
VECTICAL, CALCITRIOL
GALDERMA R AND D
* GALDERMA RESEARCH AND DEVELOPMENT INC
AKLIEF, TRIFAROTENE
GALEN SPECIALTY
* GALEN SPECIALTY PHARMA US LLC
SYNERA, LIDOCAINE
GALT PHARMS
* GALT PHARMACEUTICALS LLC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 75

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GALT PHARMACEUTICALS LLC
DORAL, QUAZEPAM
GATE PHARMS
* GATE PHARMACEUTICALS
LINEZOLID, LINEZOLID
GD SEARLE
* GD SEARLE LLC
CELEBREX, CELECOXIB
DAYPRO, OXAPROZIN
GD SEARLE LLC
* GD SEARLE LLC
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ARTHROTEC, DICLOFENAC SODIUM
CYTOTEC, MISOPROSTOL
FLAGYL, METRONIDAZOLE
INSPRA, EPLERENONE
LOMOTIL, ATROPINE SULFATE
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE
SYNAREL, NAFARELIN ACETATE
GE HEALTHCARE
* GE HEALTHCARE
ADREVIEW, IOBENGUANE SULFATE I-123
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
CLARISCAN, GADOTERATE MEGLUMINE
INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
OMNIPAQUE 12, IOHEXOL
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNIPAQUE 9, IOHEXOL
OMNISCAN, GADODIAMIDE
OPTISON, ALBUMIN HUMAN
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
VIZAMYL, FLUTEMETAMOL F-18
GE HLTHCARE INC
* GE HEALTHCARE INC
DATSCAN, IOFLUPANE I-123
GENBIOPRO
* GENBIOPRO INC
MIFEPRISTONE, MIFEPRISTONE
GENENTECH
* GENENTECH INC
ERIVEDGE, VISMODEGIB
NUTROPIN AQ NUSPIN, SOMATROPIN
GENENTECH INC
* GENENTECH INC
COTELLIC, COBIMETINIB FUMARATE
ESBRIET, PIRFENIDONE
ROZLYTREK, ENTRECTINIB
XOFLUZA, BALOXAVIR MARBOXIL
GENERICS
* GENERICS INTERNATIONAL VENTURES ENTERPRISES LLC
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
GENEYORK PHARMS
* GENEYORK PHARMACEUTICALS GROUP LLC
PREDNISONE, PREDNISONE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 76

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
GENUS
* GENUS LIFESCIENCES INC
HYCODAN, HOMATROPINE METHYLBROMIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
TIVORBEX, INDOMETHACIN
GENUS LIFESCIENCES
* GENUS LIFE SCIENCES INC
GOPRELTO, COCAINE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
YOSPRALA, ASPIRIN
GENZYME
* GENZYME CORP
CEREZYME, IMIGLUCERASE
CLOLAR, CLOFARABINE
MOZOBIL, PLERIXAFOR
RENAGEL, SEVELAMER HYDROCHLORIDE
RENVELA, SEVELAMER CARBONATE
THYROGEN, THYROTROPIN ALFA
GENZYME CORP
* GENZYME CORP
CAPRELSA, VANDETANIB
CERDELGA, ELIGLUSTAT TARTRATE
GILEAD
* GILEAD SCIENCES INC
CAYSTON, AZTREONAM
EMTRIVA, EMTRICITABINE
HEPSERA, ADEFOVIR DIPIVOXIL
LETAIRIS, AMBRISENTAN
RANEXA, RANOLAZINE
TRUVADA, EMTRICITABINE
GILEAD SCIENCES
* GILEAD SCIENCES LLC
ATRIPLA, EFAVIRENZ
GILEAD SCIENCES INC
* GILEAD SCIENCES INC
BIKTARVY, BICTEGRAVIR SODIUM
COMPLERA, EMTRICITABINE
DESCOVY, EMTRICITABINE
EPCLUSA, SOFOSBUVIR
GENVOYA, COBICISTAT
HARVONI, LEDIPASVIR
ODEFSEY, EMTRICITABINE
SOVALDI, SOFOSBUVIR
STRIBILD, COBICISTAT
TYBOST, COBICISTAT
VEMLIDY, TENOFOVIR ALAFENAMIDE FUMARATE
VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VOSEVI, SOFOSBUVIR
ZYDELIG, IDELALISIB
GISKIT
* GISKIT BV
EXEM FOAM KIT, AIR POLYMER-TYPE A
GLAND PHARMA LTD
* GLAND PHARMA LTD
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
AZITHROMYCIN, AZITHROMYCIN
BIMATOPROST, BIMATOPROST
CARBOPLATIN, CARBOPLATIN
CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE
CISPLATIN, CISPLATIN
CLOFARABINE, CLOFARABINE
CYTARABINE, CYTARABINE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 77

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GLAND PHARMA LTD
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ETOMIDATE, ETOMIDATE
FLUOROURACIL, FLUOROURACIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM, HEPARIN SODIUM
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MEROPENEM, MEROPENEM
MESNA, MESNA
METHOCARBAMOL, METHOCARBAMOL
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PACITAXEL, PACLITAXEL
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
TEMSIROLIMUS, TEMSIROLIMUS
TRANEXAMIC ACID, TRANEXAMIC ACID
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
ZIPRASIDONE MESYLATE, ZIPRASIDONE MESYLATE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ZOLEDRONIC, ZOLEDRONIC ACID
GLASSHOUSE PHARMS
* GLASSHOUSE PHARMACEUTICALS LTD CANADA
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
GLAXO GRP ENGLAND
* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
INCRUSE ELLIPTA, UMECLIDINIUM BROMIDE
GLAXO GRP LTD
* GLAXO GROUP LTD DBA GLAXOSMITHKLINE
FLOVENT HFA, FLUTICASONE PROPIONATE
* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
BREO ELLIPTA, FLUTICASONE FUROATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
GLAXOSMITHKLINE
* GLAXOSMITHKLINE
ABREVA, DOCOSANOL (OTC)
AVODART, DUTASTERIDE
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
EPIVIR-HBV, LAMIVUDINE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 78

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GLAXOSMITHKLINE
IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
JALYN, DUTASTERIDE
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
RELENZA, ZANAMIVIR
VALTREX, VALACYCLOVIR HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
* GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MULTI-SYMPTOM COLD & FLU, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ADVIL, IBUPROFEN (OTC)
ADVIL, IBUPROFEN SODIUM (OTC)
ALAVERT, LORATADINE (OTC)
AXID AR, NIZATIDINE (OTC)
CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)
INFANT'S ADVIL, IBUPROFEN (OTC)
JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
LORATADINE, LORATADINE (OTC)
* GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
ANORO ELLIPTA, UMECLIDINIUM BROMIDE
ARNUITY ELLIPTA, FLUTICASONE FUROATE
KRINTAFEL, TAFENOQUINE SUCCINATE
TRELEGY ELLIPTA, FLUTICASONE FUROATE
* GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
SEREVENT, SALMETEROL XINAFOATE
VENTOLIN HFA, ALBUTEROL SULFATE
GLAXOSMITHKLINE CON
* GLAXOSMITHKLINE CONSUMER HEALTH
TRANSDERM SCOP, SCOPOLAMINE
GLAXOSMITHKLINE CONS
* GLAXOSMITHKLINE CONSUMER HEALTHCARE
ALLI, ORLISTAT (OTC)
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC)
FLONASE SENSIMIST ALLERGY RELIEF, FLUTICASONE FUROATE (OTC)
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
VOLTAREN, DICLOFENAC SODIUM
GLAXOSMITHKLINE LLC
* GLAXOSMITHKLINE LLC
AMERGE, NARATRIPTAN HYDROCHLORIDE
DYAZIDE, HYDROCHLOROTHIAZIDE
FLOLAN, EPOPROSTENOL SODIUM
LAMICTAL CD, LAMOTRIGINE
LAMICTAL ODT, LAMOTRIGINE
LAMICTAL XR, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
MEPRON, ATOVAQUONE
REQUIP XL, ROPINIROLE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 79

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GLAXOSMITHKLINE LLC
REQUIP, ROPINIROLE HYDROCHLORIDE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
GLENMARK
* GLENMARK THERAPEUTICS INC USA
ECOZA, ECONAZOLE NITRATE
GLENMARK GENERICS
* GLENMARK GENERICS INC USA
ADAPALENE, ADAPALENE
ADAPALENE, ADAPALENE (OTC)
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
IMIQUIMOD, IMIQUIMOD
MOMETASONE FUROATE, MOMETASONE FUROATE
NIZATIDINE, NIZATIDINE
ZONISAMIDE, ZONISAMIDE
* GLENMARK GENERICS LIMITED
BRIELLYN, ETHINYL ESTRADIOL
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* GLENMARK GENERICS LTD
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
ALYACEN 1/35, ETHINYL ESTRADIOL
ALYACEN 7/7/7, ETHINYL ESTRADIOL
ASHLYNA, ETHINYL ESTRADIOL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
CARVEDILOL, CARVEDILOL
CICLOPIROX, CICLOPIROX
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESOXIMETASONE, DESOXIMETASONE
ESZOPICLONE, ESZOPICLONE
FELODIPINE, FELODIPINE
FLUCONAZOLE, FLUCONAZOLE
FLUOCINONIDE, FLUOCINONIDE
HEATHER, NORETHINDRONE
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LITHIUM CARBONATE, LITHIUM CARBONATE
MARLISSA, ETHINYL ESTRADIOL
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NAPROXEN, NAPROXEN
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
URSODIOL, URSODIOL
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VIORELE, DESOGESTREL
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 80

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GLENMARK GENERICS LTD
ZOLMITRIPTAN, ZOLMITRIPTAN
* GLENMARK GENERICS LTD INDIA
INDOMETHACIN, INDOMETHACIN
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
GLENMARK PHARMS
* GLENMARK PHARMACEUTICALS INC
TERIFLUNOMIDE, TERIFLUNOMIDE
* GLENMARK PHARMACEUTICALS INC USA
CICLOPIROX, CICLOPIROX
CLOTRIMAZOLE, CLOTRIMAZOLE
MUPIROCIN, MUPIROCIN
* GLENMARK PHARMACEUTICALS LTD
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
* GLENMARK PHARMACEUTICALS SA
ABIRATERONE ACETATE, ABIRATERONE ACETATE
ATOVAQUONE, ATOVAQUONE
AZELAIC ACID, AZELAIC ACID
CALCIPOTRIENE, CALCIPOTRIENE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
DESONIDE, DESONIDE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
HAILEY 1.5/30, ETHINYL ESTRADIOL
HAILEY FE 1.5/30, ETHINYL ESTRADIOL
LINEZOLID, LINEZOLID
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
GLENMARK PHARMS INC
* GLENMARK PHARMACEUTICALS INC USA
CALCIPOTRIENE, CALCIPOTRIENE
FULVESTRANT, FULVESTRANT
LITHIUM CARBONATE, LITHIUM CARBONATE
MUPIROCIN, MUPIROCIN CALCIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
GLENMARK PHARMS LTD
* GLENMARK PHARMACEUTICALS LTD
ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE
AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESONIDE, DESONIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
ESTRADIOL, ESTRADIOL
EZETIMIBE AND SIMVASTATIN, EZETIMIBE
EZETIMIBE, EZETIMIBE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FLUCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE ACETONIDE, FLUOCINOLONE ACETONIDE
FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE
GABAPENTIN, GABAPENTIN
HAILEY FE 1/20, ETHINYL ESTRADIOL
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
INDOMETHACIN, INDOMETHACIN
LAMOTRIGINE, LAMOTRIGINE
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL (OTC)
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 81

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GLENMARK PHARMACEUTICALS LTD
LIDOCAINE, LIDOCAINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
OXCARBAZEPINE, OXCARBAZEPINE
PIMECROLIMUS, PIMECROLIMUS
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RANOLAZINE, RANOLAZINE
RILUZOLE, RILUZOLE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
RUFINAMIDE, RUFINAMIDE
SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE
TACROLIMUS, TACROLIMUS
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TELMISARTAN, TELMISARTAN
TRETINOIN, TRETINOIN
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VORICONAZOLE, VORICONAZOLE
GLENMARK PHARMS SA
* GLENMARK PHARMACEUTICALS SA SWITZERLAND
ACYCLOVIR, ACYCLOVIR
APREPITANT, APREPITANT
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
NITROGLYCERIN, NITROGLYCERIN
GLOBAL BLOOD THERAPS
* GLOBAL BLOOD THERAPEUTICS INC
OXBRYTA, VOXELOTOR
GRANULES INDIA
* GRANULES INDIA LTD
IBUPROFEN, IBUPROFEN (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
GRANULES INDIA LTD
* GRANULES INDIA LTD
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
GABAPENTIN, GABAPENTIN
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LORATADINE, LORATADINE (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHOCARBAMOL, METHOCARBAMOL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
GRANULES PHARMS
* GRANULES PHARMACEUTICALS INC
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
GRAVITI PHARMS
* GRAVITI PHARMACEUTICALS PRIVATE LTD
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
GUARDIAN DRUG
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 82

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **
* GUARDIAN DRUG CO
GUAIFENESIN, GUAIFENESIN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LORATADINE, LORATADINE (OTC)
GUERBET
* GUERBET LLC
DOTAREM, GADOTERATE MEGLUMINE
LIPIODOL, ETHIODIZED OIL
GW RES LTD
* GW RESEARCH LTD
EPIDIOLEX, CANNABIDIOL
HANFORD GC
* GC HANFORD MANUFACTURING CO
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
POHL BOSKAMP
* G POHL BOSKAMP GMBH AND CO KG
GONITRO, NITROGLYCERIN
** H **
HAEMONETICS
* HAEMONETICS CORP
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
HAINAN POLY PHARM
* HAINAN POLY PHARMACEUTICAL CO LTD
AZITHROMYCIN, AZITHROMYCIN
EPTIFIBATIDE, EPTIFIBATIDE
GANCICLOVIR SODIUM, GANCICLOVIR SODIUM
LEVETIRACETAM, LEVETIRACETAM
VORICONAZOLE, VORICONAZOLE
HALOCARBON PRODS
* HALOCARBON PRODUCTS CORP
ISOFLURANE, ISOFLURANE
SEVOFLURANE, SEVOFLURANE
HALOZYME THERAP
* HALOZYME THERAPEUTICS INC
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HAMELN PHARMA PLUS
* HAMELN PHARMA PLUS GMBH
PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM
PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM
HANGZHOU BINJIANG
* HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
HANSAMED INC
* HANSAMED INC
ULTACAN FORTE, ARTICAINE HYDROCHLORIDE
ULTACAN, ARTICAINE HYDROCHLORIDE
HARMONY
* HARMONY BIOSCIENCES LLC
WAKIX, PITOLISANT HYDROCHLORIDE
HARRIS PHARM
* HARRIS PHARMACEUTICAL INC
FLUCONAZOLE, FLUCONAZOLE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
HBT LABS INC
* HBT LABS INC
FULVESTRANT, FULVESTRANT
HEBEI CHANGSHAN
* HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
HEC PHARM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 83

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HEC PHARM USA INC
CLARITHROMYCIN, CLARITHROMYCIN
LEVOFLOXACIN, LEVOFLOXACIN
PRASUGREL, PRASUGREL HYDROCHLORIDE
HEC PHARM CO LTD
* HEC PHARM CO LTD
FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE
HELSINN
* HELSINN BIREX PHARMACEUTICALS LTD
VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE
HELSINN HLTHCARE
* HELSINN HEALTHCARE SA
AKYNZEO, FOSNETUPITANT CHLORIDE HYDROCHLORIDE
AKYNZEO, NETUPITANT
ALOXI, PALONOSETRON HYDROCHLORIDE
HERCON PHARM
* HERCON PHARMACEUTICAL LLC
NITROGLYCERIN, NITROGLYCERIN
HERITAGE LIFE
* HERITAGE LIFE SCIENCES BARBADOS INC
CLOZARIL, CLOZAPINE
HERITAGE PHARMA
* HERITAGE PHARMA LABS INC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETAZOLAMIDE, ACETAZOLAMIDE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BUMETANIDE, BUMETANIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DIFLUNISAL, DIFLUNISAL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
INDOMETHACIN, INDOMETHACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METHYLDOPA, METHYLDOPA
METOPROLOL TARTRATE, METOPROLOL TARTRATE
NADOLOL, NADOLOL
NIFEDIPINE, NIFEDIPINE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
HERITAGE PHARMS INC
* HERITAGE PHARMACEUTICALS INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ACYCLOVIR, ACYCLOVIR
CALCIUM ACETATE, CALCIUM ACETATE
CARISOPRODOL AND ASPIRIN, ASPIRIN
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
DUTASTERIDE, DUTASTERIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 84

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HERITAGE PHARMACEUTICALS INC
ETHOSUXIMIDE, ETHOSUXIMIDE
FELODIPINE, FELODIPINE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE, GLYBURIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDOMETHACIN, INDOMETHACIN
KETOPROFEN, KETOPROFEN
LEFLUNOMIDE, LEFLUNOMIDE
METRONIDAZOLE, METRONIDAZOLE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NIMODIPINE, NIMODIPINE
NYSTATIN, NYSTATIN
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
HERON THERAPS INC
* HERON THERAPEUTICS INC
CINVANTI, APREPITANT
SUSTOL, GRANISETRON
HETERO LABS LTD
* HETERO LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
HETERO LABS LTD III
* HETERO LABS LTD UNIT III
ABACAVIR SULFATE, ABACAVIR SULFATE
ATOVAQUONE, ATOVAQUONE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLOBAZAM, CLOBAZAM
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
EFAVIRENZ, EFAVIRENZ
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
FENOFIBRATE, FENOFIBRATE
FINASTERIDE, FINASTERIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE HYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
METHOCARBAMOL, METHOCARBAMOL
NEVIRAPINE, NEVIRAPINE
OMEPRAZOLE, OMEPRAZOLE
OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE
PREGABALIN, PREGABALIN
RITONAVIR, RITONAVIR
ROFLUMILAST, ROFLUMILAST
SIMVASTATIN, SIMVASTATIN
TADALAFIL, TADALAFIL
TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
TORSEMIDE, TORSEMIDE
ZIDOVUDINE, ZIDOVUDINE
HETERO LABS LTD V
* HETERO LABS LTD UNIT V
ACYCLOVIR, ACYCLOVIR
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 85

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HETERO LABS LTD UNIT V
ARIPIPRAZOLE, ARIPIPRAZOLE
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ENTECAVIR, ENTECAVIR
FAMCICLOVIR, FAMCICLOVIR
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
IRBESARTAN, IRBESARTAN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LEVOFLOXACIN, LEVOFLOXACIN
LINEZOLID, LINEZOLID
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TELMISARTAN, TELMISARTAN
TETRABENAZINE, TETRABENAZINE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VALSARTAN, VALSARTAN
HEYL CHEMISCH
* HEYL CHEMISCH PHARMAZEUTISHE FABRIK
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
HI TECH
* HI-TECH PHARMACAL CO INC
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BIMATOPROST, BIMATOPROST
BROMFENAC SODIUM, BROMFENAC SODIUM
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
DESONIDE, DESONIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
IBUPROFEN, IBUPROFEN
MEGESTROL ACETATE, MEGESTROL ACETATE
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE
TRIFLURIDINE, TRIFLURIDINE
* HI-TECH PHARMACAL CO INC AN AKORN CO
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)
LOTEPREDNOL ETABONATE, LOTEPREDNOL ETABONATE
HI TECH PHARMA
* HI TECH PHARMACAL CO INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CALCIPOTRIENE, CALCIPOTRIENE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CICLOPIROX, CICLOPIROX
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CORMAX, CLOBETASOL PROPIONATE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
EMBELINE E, CLOBETASOL PROPIONATE
EMBELINE, CLOBETASOL PROPIONATE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LACTULOSE, LACTULOSE
LEVOCARNITINE, LEVOCARNITINE
LEVOFLOXACIN, LEVOFLOXACIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 86

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HI TECH PHARMACAL CO INC
LIDOCAINE AND PRILOCAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TIMOLOL MALEATE, TIMOLOL MALEATE
VOSOL HC, ACETIC ACID, GLACIAL
VOSOL, ACETIC ACID, GLACIAL
HI TECH PHARMA CO
* HI TECH PHARMACAL CO INC
FLUNISOLIDE, FLUNISOLIDE
PREDNISOLONE, PREDNISOLONE
HI-TECH PHARMA CO
* HI-TECH PHARMACAL CO INC
FAMOTIDINE, FAMOTIDINE
GATIFLOXACIN, GATIFLOXACIN
LORAZEPAM, LORAZEPAM
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE
HI-TECH PHARMACAL
* HI-TECH PHARMACAL CO INC
LEVETIRACETAM, LEVETIRACETAM
HIGH TECH PHARMA
* HIGH TECHNOLOGY PHARMACAL CO INC
VALPROIC ACID, VALPROIC ACID
HIKMA
* HIKMA FARMACEUTICA LDA
CEFOTAXIME, CEFOTAXIME SODIUM
* HIKMA FARMACEUTICA PORTUGAL SA
CEFOTETAN, CEFOTETAN DISODIUM
CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM
ETOMIDATE, ETOMIDATE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
* HIKMA PHARMACEUTICALS
AMOXICILLIN, AMOXICILLIN
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEPHALEXIN, CEPHALEXIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
GLYBURIDE (MICRONIZED), GLYBURIDE
* HIKMA PHARMACEUTICALS INTERNATIONAL LTD
ATIVAN, LORAZEPAM
CAFCIT, CAFFEINE CITRATE
CIMETIDINE, CIMETIDINE
CODEINE SULFATE, CODEINE SULFATE
DIGOXIN, DIGOXIN
DOPRAM, DOXAPRAM HYDROCHLORIDE
FUROSEMIDE, FUROSEMIDE
HEPARIN SODIUM, HEPARIN SODIUM
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
MORPHINE SULFATE, MORPHINE SULFATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 87

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HIKMA PHARMACEUTICALS INTERNATIONAL LTD
ROBAXIN, METHOCARBAMOL
RUFINAMIDE, RUFINAMIDE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
* HIKMA PHARMACEUTICALS LLC
PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
* HIKMA PHARMACEUTICALS USA INC
ACARBOSE, ACARBOSE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BOSENTAN, BOSENTAN
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE
CAPECITABINE, CAPECITABINE
CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOBAZAM, CLOBAZAM
CLOTRIMAZOLE, CLOTRIMAZOLE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DALFAMPRIDINE, DALFAMPRIDINE
DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE
DEXAMETHASONE INTENSOL, DEXAMETHASONE
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM INTENSOL, DIAZEPAM
DIAZEPAM, DIAZEPAM
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DISULFIRAM, DISULFIRAM
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
DUTASTERIDE, DUTASTERIDE
ESZOPICLONE, ESZOPICLONE
ETHACRYNIC ACID, ETHACRYNIC ACID
EVEROLIMUS, EVEROLIMUS
EXEMESTANE, EXEMESTANE
FAMCICLOVIR, FAMCICLOVIR
FEBUXOSTAT, FEBUXOSTAT
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUCYTOSINE, FLUCYTOSINE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)
FUROSEMIDE, FUROSEMIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMATINIB MESYLATE, IMATINIB MESYLATE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LACTULOSE, LACTULOSE
LETROZOLE, LETROZOLE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 88

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HIKMA PHARMACEUTICALS USA INC
LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
LINEZOLID, LINEZOLID
LITHIUM CARBONATE, LITHIUM CARBONATE
LORAZEPAM INTENSOL, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE
PREDNISONE INTENSOL, PREDNISONE
PREDNISONE, PREDNISONE
PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE
RITONAVIR, RITONAVIR
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROXICET, ACETAMINOPHEN
RUFINAMIDE, RUFINAMIDE
SODIUM OXYBATE, SODIUM OXYBATE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TETRABENAZINE, TETRABENAZINE
TINIDAZOLE, TINIDAZOLE
TORSEMIDE, TORSEMIDE
TRIAZOLAM, TRIAZOLAM
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
HIKMA FARMACEUTICA
* HIKMA FARMACEUTICA (PORTUGAL) SA
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 89

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HIKMA FARMACEUTICA (PORTUGAL) SA
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
VALPROATE SODIUM, VALPROATE SODIUM
* HIKMA FARMACEUTICA PORTUGAL LDA
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
* HIKMA FARMACEUTICA PORTUGAL SA
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
* HIKMA FARMACEUTICA SA
ZOLEDRONIC ACID, ZOLEDRONIC ACID
HIKMA INTL PHARMS
* HIKMA INTERNATIONAL PHARMACEUTICALS LLC
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN
CAPTOPRIL, CAPTOPRIL
CARISOPRODOL, CARISOPRODOL
CORTISONE ACETATE, CORTISONE ACETATE
DIGOXIN, DIGOXIN
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCORTISONE, HYDROCORTISONE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHOCARBAMOL, METHOCARBAMOL
MITIGARE, COLCHICINE
PRIMIDONE, PRIMIDONE
HIKMA PHARM CO LTD
* HIKMA PHARM CO LTD
ARGATROBAN, ARGATROBAN
HIKMA PHARMS
* HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
GEMFIBROZIL, GEMFIBROZIL
LETROZOLE, LETROZOLE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
RIFAMPIN, RIFAMPIN
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
* HIKMA PHARMACEUTICALS CO LTD
PARICALCITOL, PARICALCITOL
* HIKMA PHARMACEUTICALS LLC
ABIRATERONE ACETATE, ABIRATERONE ACETATE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 90

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HIKMA PHARMACEUTICALS LLC
DANTROLENE SODIUM, DANTROLENE SODIUM
DOXERCALCIFEROL, DOXERCALCIFEROL
FOLIC ACID, FOLIC ACID
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
OLANZAPINE, OLANZAPINE
PIROXICAM, PIROXICAM
PREDNISONE, PREDNISONE
ZALEPLON, ZALEPLON
HILL DERMAC
* HILL DERMACEUTICALS INC
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE
DERMOTIC, FLUOCINOLONE ACETONIDE
HILL DERMACEUTICALS
* HILL DERMACEUTICALS INC
TOLAK, FLUOROURACIL
HISAMITSU
* HISAMITSU PHARMACEUTICAL CO INC
SECUADO, ASENAPINE
HISAMITSU PHARM CO
* HISAMITSU PHARMACEUTICAL CO INC
SALONPAS, MENTHOL (OTC)
HISUN PHARM HANGZHOU
* HISUN PHARMACEUTICAL (HANGZHOU) CO LTD
CLADRIBINE, CLADRIBINE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
* HISUN PHARMACEUTICAL HANGZHOU CO LTD
CAPREOMYCIN SULFATE, CAPREOMYCIN SULFATE
DACTINOMYCIN, DACTINOMYCIN
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
TICAGRELOR, TICAGRELOR
HLTHCARE
* HEALTHCARE PHARMACEUTICALS LTD
ATENOLOL, ATENOLOL
HOFFMANN LA ROCHE
* HOFFMANN LA ROCHE INC
BONIVA, IBANDRONATE SODIUM
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
XELODA, CAPECITABINE
ZELBORAF, VEMURAFENIB
HOFFMANN-LA ROCHE
* HOFFMANN-LA ROCHE INC
ALECENSA, ALECTINIB HYDROCHLORIDE
INVIRASE, SAQUINAVIR MESYLATE
HOPE PHARMS
* HOPE PHARMACEUTICALS
NITHIODOTE, SODIUM NITRITE
SODIUM NITRITE, SODIUM NITRITE
SODIUM THIOSULFATE, SODIUM THIOSULFATE
HORIZON
* HORIZON MEDICINES LLC
DUEXIS, FAMOTIDINE
VIMOVO, ESOMEPRAZOLE MAGNESIUM
* HORIZON THERAPEUTICS IRELAND DAC
PENNSAID, DICLOFENAC SODIUM
HORIZON PHARMA USA
* HORIZON PHARMA USA INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 91

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HORIZON PHARMA USA INC
PROCYSBI, CYSTEAMINE BITARTRATE
RAYOS, PREDNISONE
HORIZON THERAP
* HORIZON THERAPEUTICS LLC
BUPHENYL, SODIUM PHENYLBUTYRATE
RAVICTI, GLYCEROL PHENYLBUTYRATE
HOSPIRA
* HOSPIRA INC
ACETYLCYSTEINE, ACETYLCYSTEINE
ALFENTANIL, ALFENTANIL HYDROCHLORIDE
AMIDATE, ETOMIDATE
AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE, ATROPINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUMETANIDE, BUMETANIDE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CORLOPAM, FENOLDOPAM MESYLATE
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DEXTROSE 25%, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50%, DEXTROSE
DIAZEPAM, DIAZEPAM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DROPERIDOL, DROPERIDOL
ENALAPRILAT, ENALAPRILAT
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FUROSEMIDE, FUROSEMIDE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 92

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HOSPIRA INC
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LEVOPHED, NOREPINEPHRINE BITARTRATE
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID
M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 25%, MANNITOL
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MORPHINE SULFATE, MORPHINE SULFATE
NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM ACETATE, POTASSIUM ACETATE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
PROPOFOL, PROPOFOL
QUELICIN, SUCCINYLCHOLINE CHLORIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
SODIUM ACETATE, SODIUM ACETATE
SODIUM BICARBONATE, SODIUM BICARBONATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 93

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HOSPIRA INC
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TAZICEF, CEFTAZIDIME
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VITAMIN K1, PHYTONADIONE
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
* HOSPIRA WORLDWIDE, INC
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NITROPRESS, SODIUM NITROPRUSSIDE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
HOSPIRA INC
* HOSPIRA INC
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
BIVALIRUDIN, BIVALIRUDIN
BUSULFAN, BUSULFAN
CEFTRIAXONE, CEFTRIAXONE SODIUM
CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE
DAPTOMYCIN, DAPTOMYCIN
DOCETAXEL, DOCETAXEL
DOXERCALCIFEROL, DOXERCALCIFEROL
EPINEPHRINE (COPACKAGED), EPINEPHRINE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
INDOMETHACIN SODIUM, INDOMETHACIN SODIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID
LINEZOLID, LINEZOLID
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MAXIPIME, CEFEPIME HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MORPHINE SULFATE, MORPHINE SULFATE
NIPENT, PENTOSTATIN
PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE
PARICALCITOL, PARICALCITOL
SODIUM BICARBONATE, SODIUM BICARBONATE
TACROLIMUS, TACROLIMUS
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
HOSPIRA WORLDWIDE
* HOSPIRA WORLDWIDE PTY
OXALIPLATIN, OXALIPLATIN
HOT SHOTS NM LLC
* HOT SHOTS NUCLEAR MEDICINE LLC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
HQ SPCLT PHARMA
* HQ SPECIALTY PHARMA CORP
CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE
CISPLATIN, CISPLATIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 94

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HQ SPECIALTY PHARMA CORP
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
LINEZOLID, LINEZOLID
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MEROPENEM, MEROPENEM
HQ SPECIALITY PHARMA
* HQ SPECIALITY PHARMA LLC
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
HRA PHARMA
* HRA PHARMA RARE DISEASES
LYSODREN, MITOTANE
METOPIRONE, METYRAPONE
HUMANWELL PURACAP
* HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD
DUTASTERIDE, DUTASTERIDE
IBUPROFEN, IBUPROFEN (OTC)
HUONS
* HUONS CO LTD
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
ROCHE
* HOFFMANN LA ROCHE INC
BONIVA, IBANDRONATE SODIUM
FUZEON, ENFUVIRTIDE
KLONOPIN, CLONAZEPAM
TAMIFLU, OSELTAMIVIR PHOSPHATE
VALIUM, DIAZEPAM
SHUANGCHENG
* HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD
BIVALIRUDIN, BIVALIRUDIN
PREGABALIN, PREGABALIN
** I **
ICHNOS
* ICHNOS SCIENCES SA
DEFERASIROX, DEFERASIROX
ICU MEDICAL INC
* ICU MEDICAL INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MORPHINE SULFATE, MORPHINE SULFATE
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 95

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **
* ICU MEDICAL INC
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
IDENTI PHARMS INC
* IDENTI PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
IDT AUSTRALIA LTD
* IDT AUSTRALIA LTD
TEMOZOLOMIDE, TEMOZOLOMIDE
IMPACT
* IMPACT BIOMEDICINES INC A WHOLLY OWNED SUB OF CELGENE CORP
INREBIC, FEDRATINIB HYDROCHLORIDE
IMPAX
* IMPAX LABORATORIES LLC
ADRENACLICK, EPINEPHRINE
IMPAX LABS
* IMPAX LABORATORIES INC
ACARBOSE, ACARBOSE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE
DANTROLENE SODIUM, DANTROLENE SODIUM
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DIGOXIN, DIGOXIN
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
OMEPRAZOLE, OMEPRAZOLE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RILUZOLE, RILUZOLE
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
IMPAX LABS INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 96

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **
* IMPAX LABORATORIES INC
ACITRETIN, ACITRETIN
ALBENZA, ALBENDAZOLE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
BUDESONIDE, BUDESONIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE
COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
EMVERM, MEBENDAZOLE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
LAMOTRIGINE, LAMOTRIGINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
METHENAMINE HIPPURATE, METHENAMINE HIPPURATE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MORPHINE SULFATE, MORPHINE SULFATE
NABUMETONE, NABUMETONE
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RYTARY, CARBIDOPA
SEVELAMER CARBONATE, SEVELAMER CARBONATE
URSODIOL, URSODIOL
IMPAX PHARMS
* IMPAX PHARMACEUTICALS
GEMFIBROZIL, GEMFIBROZIL
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
INCYTE CORP
* INCYTE CORP
JAKAFI, RUXOLITINIB PHOSPHATE
INDICUS PHARMA
* INDICUS PHARMA LLC
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LETROZOLE, LETROZOLE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
INDIVIOR INC
* INDIVIOR INC
BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
PERSERIS KIT, RISPERIDONE
SUBLOCADE, BUPRENORPHINE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
INDOCO REMEDIES
* INDOCO REMEDIES LTD
ALLOPURINOL, ALLOPURINOL
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
FEBUXOSTAT, FEBUXOSTAT
GLIMEPIRIDE, GLIMEPIRIDE
RASAGILINE MESYLATE, RASAGILINE MESYLATE
INFORLIFE
* INFORLIFE SA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 97

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **
* INFORLIFE SA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
INGENUS PHARMS LLC
* INGENUS PHARMACEUTICALS LLC
ARSENIC TRIOXIDE, ARSENIC TRIOXIDE
CABERGOLINE, CABERGOLINE
CARBOPLATIN, CARBOPLATIN
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOFARABINE, CLOFARABINE
DECITABINE, DECITABINE
DOCETAXEL, DOCETAXEL
FLUOROURACIL, FLUOROURACIL
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM
OXALIPLATIN, OXALIPLATIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
INGENUS PHARMS NJ
* INGENUS PHARMACEUTICALS NJ LLC
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
INNOGENIX
* INNOGENIX LLC
HALOPERIDOL, HALOPERIDOL
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
METRONIDAZOLE, METRONIDAZOLE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
INSMED INC
* INSMED INC
ARIKAYCE KIT, AMIKACIN SULFATE
INST BIOCHEM
* INSTITUT BIOCHEMIQUE SA
FLECTOR, DICLOFENAC EPOLAMINE
INSTITUT BIOCHIMIQUE
* INSTITUT BIOCHIMIQUE SA (IBSA)
TIROSINT, LEVOTHYROXINE SODIUM
TIROSINT-SOL, LEVOTHYROXINE SODIUM
INSYS DEV CO INC
* INSYS DEVELOPMENT CO INC
SYNDROS, DRONABINOL
INTAS PHARMS USA
* INTAS PHARMACEUTICALS USA
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
INTELLIPHARMACEUTICS
* INTELLIPHARMACEUTICS CORP
DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
INTERCEPT PHARMS INC
* INTERCEPT PHARMACEUTICALS INC
OCALIVA, OBETICHOLIC ACID
INTERGEL PHARM
* INTERGEL PHARMACEUTICAL INC
NIFEDIPINE, NIFEDIPINE
INTERGEL PHARMS INC
* INTERGEL PHARMACEUTICALS INC
DUTASTERIDE, DUTASTERIDE
INTERPHARMA PRAHA AS
* INTERPHARMA PRAHA AS
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 98

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **
* INTERPHARMA PRAHA AS
ORALTAG, IOHEXOL
INTERSECT ENT INC
* INTERSECT ENT INC
SINUVA, MOMETASONE FUROATE
INTL MEDICATED
* INTERNATIONAL MEDICATED SYSTEMS LTD
MILRINONE LACTATE, MILRINONE LACTATE
INTL MEDICATION
* INTERNATIONAL MEDICATION SYSTEM
LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
PHYTONADIONE, PHYTONADIONE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
* INTERNATIONAL MEDICATION SYSTEMS LTD
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
INTL MEDICATION SYS
* INTERNATIONAL MEDICATION SYSTEMS LTD
CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE
LORAZEPAM, LORAZEPAM
SODIUM BICARBONATE, SODIUM BICARBONATE
INTRA-CELLULAR
* INTRA-CELLULAR THERAPIES INC
CAPLYTA, LUMATEPERONE TOSYLATE
INVAGEN PHARMS
* INVAGEN PHARMACEUTICALS INC
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CALCIUM ACETATE, CALCIUM ACETATE
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
MEPROBAMATE, MEPROBAMATE
NABUMETONE, NABUMETONE
NADOLOL, NADOLOL
NAPROXEN, NAPROXEN
OLANZAPINE, OLANZAPINE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PREGABALIN, PREGABALIN
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SEVELAMER CARBONATE, SEVELAMER CARBONATE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 99

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **
* INVAGEN PHARMACEUTICALS INC
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
VIGABATRIN, VIGABATRIN
WARFARIN SODIUM, WARFARIN SODIUM
ZOLMITRIPTAN, ZOLMITRIPTAN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
INVATECH
* INVATECH PHARMA SOLUTIONS LLC
DIVALPROEX SODIUM, DIVALPROEX SODIUM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
INVENTIA
* INVENTIA HEALTHCARE LTD
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
LANSOPRAZOLE, LANSOPRAZOLE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PALIPERIDONE, PALIPERIDONE
TELMISARTAN, TELMISARTAN
INVENTIA HLTHCARE
* INVENTIA HEALTHCARE PRIVATE LTD
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
IONETIX
* IONETIX CORP
AMMONIA N 13, AMMONIA N-13
IPCA LABS LTD
* IPCA LABORATORIES LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
IPR
* IPR PHARMACEUTICALS INC
CRESTOR, ROSUVASTATIN CALCIUM
ZOMIG, ZOLMITRIPTAN
IPSEN INC
* IPSEN BIOPHARMACEUTICALS INC
INCRELEX, MECASERMIN RECOMBINANT
ONIVYDE, IRINOTECAN HYDROCHLORIDE
IPSEN PHARMA
* IPSEN PHARMA BIOTECH SAS
SOMATULINE DEPOT, LANREOTIDE ACETATE
IRONSHORE PHARMS
* IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC
JORNAY PM, METHYLPHENIDATE HYDROCHLORIDE
ISO TEX
* ISO TEX DIAGNOSTICS INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 100

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **
* ISO TEX DIAGNOSTICS INC
JEANATOPE, ALBUMIN IODINATED I-125 SERUM
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
ISOTEX
* ISOTEX DIAGNOSTICS
GLOFIL-125, IOTHALAMATE SODIUM I-125
ISTITUTO BIO ITA SPA
* ISTITUTO BIOCHIMICO ITALIANO SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PIPERACILLIN, PIPERACILLIN SODIUM
ITALFARMACO SPA
* ITALFARMACO SPA
TIGLUTIK KIT, RILUZOLE
IVAX PHARMS
* IVAX PHARMACEUTICALS INC
VALSARTAN, VALSARTAN
IVAX PHARMS INC
* IVAX PHARMACEUTICALS INC
OLANZAPINE, OLANZAPINE
IVAX SUB TEVA PHARMS
* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
BACLOFEN, BACLOFEN
CABERGOLINE, CABERGOLINE
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CIMETIDINE, CIMETIDINE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLOZAPINE, CLOZAPINE
CYCLOSPORINE, CYCLOSPORINE
DIAZEPAM, DIAZEPAM
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
FAMOTIDINE, FAMOTIDINE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
OXAPROZIN, OXAPROZIN
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
** J **
J AND J CONSUMER INC
* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)
MOTRIN IB, IBUPROFEN (OTC)
PEPCID AC, FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
SINE-AID IB, IBUPROFEN (OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
TYLENOL, ACETAMINOPHEN (OTC)
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)
JACOBUS
* JACOBUS PHARMACEUTICAL CO
DAPSONE, DAPSONE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 101

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **
* JACOBUS PHARMACEUTICAL CO
PASER, AMINOSALICYLIC ACID
JACOBUS PHARM CO INC
* JACOBUS PHARMACEUTICAL CO INC
RUZURGI, AMIFAMPRIDINE
JANSSEN BIOTECH
* JANSSEN BIOTECH INC
BALVERSA, ERDAFITINIB
ERLEADA, APALUTAMIDE
ZYTIGA, ABIRATERONE ACETATE
JANSSEN PHARMS
* JANSSEN PHARMACEUTICALS INC
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
DITROPAN XL, OXYBUTYNIN CHLORIDE
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-37, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
ELMIRON, PENTOSAN POLYSULFATE SODIUM
HALDOL, HALOPERIDOL DECANOATE
HALDOL, HALOPERIDOL LACTATE
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
INVEGA TRINZA, PALIPERIDONE PALMITATE
INVEGA, PALIPERIDONE
INVOKAMET XR, CANAGLIFLOZIN
INVOKAMET, CANAGLIFLOZIN
INVOKANA, CANAGLIFLOZIN
NIZORAL, KETOCONAZOLE
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
RAZADYNE, GALANTAMINE HYDROBROMIDE
RISPERDAL CONSTA, RISPERIDONE
RISPERDAL, RISPERIDONE
SPORANOX, ITRACONAZOLE
SPRAVATO, ESKETAMINE HYDROCHLORIDE
TOPAMAX, TOPIRAMATE
TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN
TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN
ULTRACET, ACETAMINOPHEN
ULTRAM, TRAMADOL HYDROCHLORIDE
XARELTO, RIVAROXABAN
JANSSEN PRODS
* JANSSEN PRODUCTS LP
EDURANT, RILPIVIRINE HYDROCHLORIDE
PREZCOBIX, COBICISTAT
PREZISTA, DARUNAVIR
SYMTUZA, COBICISTAT
YONDELIS, TRABECTEDIN
JANSSEN R AND D
* JANSSEN RESEARCH AND DEVELOPMENT LLC
INTELENCE, ETRAVIRINE
JANSSEN THERAP
* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP
SIRTURO, BEDAQUILINE FUMARATE
JAZZ
* JAZZ PHARMACEUTICALS IRELAND LTD
SUNOSI, SOLRIAMFETOL
JAZZ PHARMS
* JAZZ PHARMACEUTICALS INC
XYREM, SODIUM OXYBATE
JAZZ PHARMS INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 102

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **
* JAZZ PHARMACEUTICALS INC
DEFITELIO, DEFIBROTIDE SODIUM
JDP
* JDP THERAPEUTICS LLC
QUZYTTIR, CETIRIZINE HYDROCHLORIDE
JIANGSU HANSOH PHARM
* JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
JIANGSU HENGRUI MED
* JIANGSU HENGRUI MEDICINE CO LTD
CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE
CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE
CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DAPTOMYCIN, DAPTOMYCIN
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DOCETAXEL, DOCETAXEL
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
GABAPENTIN, GABAPENTIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
OXALIPLATIN, OXALIPLATIN
THIOTEPA, THIOTEPA
JIANGXI BOYA SEEHOT
* JIANGXI BOYA SEEHOT PHARMACEUTICAL CO LTD
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
JOHNS HOPKINS UNIV
* JOHNS HOPKINS UNIV
AMMONIA N 13, AMMONIA N-13
JOHNSON AND JOHNSON
* JOHNSON AND JOHNSON CONSUMER INC
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
VISINE, NAPHAZOLINE HYDROCHLORIDE (OTC)
* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MEN'S ROGAINE, MINOXIDIL (OTC)
ROGAINE (FOR MEN), MINOXIDIL (OTC)
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
WOMEN'S ROGAINE, MINOXIDIL (OTC)
JOURNEY
* JOURNEY MEDICAL CORP
EXELDERM, SULCONAZOLE NITRATE
JUBILANT CADISTA
* JUBILANT CADISTA PHARMACEUTICALS INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
PREDNISONE, PREDNISONE
PROCOMP, PROCHLORPERAZINE MALEATE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
JUBILANT DRAXIMAGE
* JUBILANT DRAXIMAGE INC
DRAX EXAMETAZIME, TECHNETIUM TC-99M EXAMETAZIME KIT
DRAXIMAGE DTPA, TECHNETIUM TC-99M PENTETATE KIT
DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE
HICON, SODIUM IODIDE I-131
RUBY-FILL, RUBIDIUM CHLORIDE RB-82
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 103

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **
* JUBILANT DRAXIMAGE INC
SODIUM IODIDE I 131, SODIUM IODIDE I-131
* JUBILANT DRAXIMAGE RADIOPHARMACIES INC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
* JUBILANT DRAXIMAGE USA INC
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
JUBILANT GENERICS
* JUBILANT GENERICS LTD
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CELECOXIB, CELECOXIB
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FELODIPINE, FELODIPINE
INDOMETHACIN, INDOMETHACIN
IRBESARTAN, IRBESARTAN
ITRACONAZOLE, ITRACONAZOLE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NIACIN, NIACIN
OLANZAPINE, OLANZAPINE
OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
SPIRONOLACTONE, SPIRONOLACTONE
TELMISARTAN, TELMISARTAN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN, VALSARTAN
ZOLMITRIPTAN, ZOLMITRIPTAN
STEVENS J
* JEROME STEVENS PHARMACEUTICALS INC
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
DIGOXIN, DIGOXIN
METHOCARBAMOL AND ASPIRIN, ASPIRIN
UNITHROID, LEVOTHYROXINE SODIUM **
** K **
GRIFFEN
* KW GRIFFEN CO
BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)
KADMON PHARMS LLC
* KADMON PHARMACEUTICALS LLC
CLOVIQUE, TRIENTINE HYDROCHLORIDE
RIBASPHERE, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE
KAI PHARMS INC
* KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC
PARSABIV, ETELCALCETIDE
KALA PHARMS INC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 104

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **
* KALA PHARMACEUTICALS INC
INVELTYS, LOTEPREDNOL ETABONATE
KALEO INC
* KALEO INC
AUVI-Q, EPINEPHRINE
EVZIO (AUTOINJECTOR), NALOXONE HYDROCHLORIDE
KARYOPHARM THERAPS
* KARYOPHARM THERAPEUTICS INC
XPOVIO, SELINEXOR
KENTON
* KENTON CHEMICALS AND PHARMACEUTICALS CORP
ACYCLOVIR, ACYCLOVIR
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
KERYX BIOPHARMS
* KERYX BIOPHARMACEUTICALS INC
AURYXIA, FERRIC CITRATE
KETTERING MEDCTR
* KETTERING MEDCTR
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
KING PHARMS
* KING PHARMACEUTICALS INC
SYNERCID, DALFOPRISTIN
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
CYTOMEL, LIOTHYRONINE SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM **
TUSSIGON, HOMATROPINE METHYLBROMIDE
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC A SUB OF PFIZER INC
SKELAXIN, METAXALONE
KING PHARMS LLC
* KING PHARMACEUTICALS LLC
ALTACE, RAMIPRIL
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
CORZIDE, BENDROFLUMETHIAZIDE
PENICILLIN G PROCAINE, PENICILLIN G PROCAINE
SILVADENE, SILVER SULFADIAZINE
TAPAZOLE, METHIMAZOLE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
KNIGHT THERAPS
* KNIGHT THERAPEUTICS USA INC
IMPAVIDO, MILTEFOSINE
KOWA CO
* KOWA CO LTD
LIVALO, PITAVASTATIN CALCIUM
KRAMER
* KRAMER LABORATORIES INC
NIZORAL A-D, KETOCONAZOLE (OTC)
KREITCHMAN PET CTR
* KREITCHMAN PET CENTER
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
KVK TECH
* KVK TECH INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
KALEXATE, SODIUM POLYSTYRENE SULFONATE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 105

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **
* KVK TECH INC
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
KVK TECH INC
* KVK TECH INC
APADAZ, ACETAMINOPHEN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
KYOWA KIRIN
* KYOWA KIRIN INC
FARESTON, TOREMIFENE CITRATE
NOURIANZ, ISTRADEFYLLINE
SANCUSO, GRANISETRON
KYTHERA BIOPHARMS
* KYTHERA BIOPHARMACEUTICALS INC
KYBELLA, DEOXYCHOLIC ACID
** L **
L PERRIGO CO
* L PERRIGO CO
CIMETIDINE, CIMETIDINE (OTC)
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
LA JOLLA PHARMA
* LA JOLLA PHARMA LLC
GIAPREZA, ANGIOTENSIN II ACETATE
LAB HRA PHARMA
* LABORATOIRE HRA PHARMA
ELLA, ULIPRISTAL ACETATE
LABORATORIOS GRIFOLS
* LABORATORIOS GRIFOLS SA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
LABORATORIOS SALVAT
* LABORATORIOS SALVAT SA
OTOVEL, CIPROFLOXACIN HYDROCHLORIDE
LANDELA PHARM
* LANDELA PHARMACEUTICAL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LANNETT
* LANNETT CO INC
ACETAZOLAMIDE, ACETAZOLAMIDE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
LANORINAL, ASPIRIN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROBALAN, PROBENECID
LANNETT CO INC
* LANNETT CO INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ARIPIPRAZOLE, ARIPIPRAZOLE
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 106

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **
* LANNETT CO INC
BACLOFEN, BACLOFEN
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLOBAZAM, CLOBAZAM
CODEINE SULFATE, CODEINE SULFATE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DANAZOL, DANAZOL
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM, DIAZEPAM
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
DRONABINOL, DRONABINOL
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDROCORTISONE, HYDROCORTISONE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LACTULOSE, LACTULOSE
LAMIVUDINE, LAMIVUDINE
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LOPINAVIR AND RITONAVIR, LOPINAVIR
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METAXALONE, METAXALONE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MONOKET, ISOSORBIDE MONONITRATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NIACIN, NIACIN
NYSTATIN, NYSTATIN
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISOLONE, PREDNISOLONE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 107

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **
* LANNETT CO INC
RIFAMPIN, RIFAMPIN
RISPERIDONE, RISPERIDONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN, SUMATRIPTAN
TERBUTALINE SULFATE, TERBUTALINE SULFATE
THEOPHYLLINE, THEOPHYLLINE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
URSODIOL, URSODIOL
VALPROIC ACID, VALPROIC ACID
ZAROXOLYN, METOLAZONE
LANTHEUS MEDCL
* LANTHEUS MEDICAL IMAGING INC
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
DEFINITY, PERFLUTREN
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
XENON XE 133, XENON XE-133
LANTHEUS MEDICAL
* LANTHEUS MEDICAL IMAGING INC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
LARKEN LABS
* LARKEN LABORATORIES INC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
LARKEN LABS INC
* LARKEN LABORATORIES INC
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN
ALLZITAL, ACETAMINOPHEN
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
DEXAMETHASONE, DEXAMETHASONE
LAURUS LABS LTD
* LAURUS LABS LTD
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
LAVIPHARM LABS
* LAVIPHARM LABORATORIES INC
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
LEADIANT BIOSCI INC
* LEADIANT BIOSCIENCES INC
ABELCET, AMPHOTERICIN B
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE
CYSTARAN, CYSTEAMINE HYDROCHLORIDE
MATULANE, PROCARBAZINE HYDROCHLORIDE
LEADING PHARMA LLC
* LEADING PHARMA LLC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
FOLIC ACID, FOLIC ACID
FUROSEMIDE, FUROSEMIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
NIFEDIPINE, NIFEDIPINE
LEO LABS
* LEO LABORATORIES LTD
PICATO, INGENOL MEBUTATE
LEO PHARMA AS
* LEO PHARMA AS
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 108

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **
* LEO PHARMA AS
DESONATE, DESONIDE
DOVONEX, CALCIPOTRIENE
ENSTILAR, BETAMETHASONE DIPROPIONATE
FINACEA, AZELAIC ACID
PROTOPIC, TACROLIMUS
TACLONEX, BETAMETHASONE DIPROPIONATE
LEXICON PHARMS INC
* LEXICON PHARMACEUTICALS INC
XERMELO, TELOTRISTAT ETIPRATE
LG CHEM LTD
* LG CHEM LTD
FACTIVE, GEMIFLOXACIN MESYLATE
LIEBEL-FLARSHEIM
* LIEBEL-FLARSHEIM CO LLC
CONRAY, IOTHALAMATE MEGLUMINE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
MD-GASTROVIEW, DIATRIZOATE MEGLUMINE
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
LIFE MOLECULAR
* LIFE MOLECULAR IMAGING SA
NEURACEQ, FLORBETABEN F-18
LIFEPHARMA
* LIFEPHARMA FZE
LACTULOSE, LACTULOSE
LNK
* LNK INTERNATIONAL INC
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LNK INTL INC
* LNK INTERNATIONAL INC
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
LOREAL USA
* LOREAL USA PRODUCTS INC
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)
CAPITAL SOLEIL 15, AVOBENZONE (OTC)
LOTUS PHARM CO LTD
* LOTUS PHARMACEUTICAL CO LTD
LEVETIRACETAM, LEVETIRACETAM
* LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT
CALCIUM ACETATE, CALCIUM ACETATE
LEVETIRACETAM, LEVETIRACETAM
LUITPOLD
* LUITPOLD PHARMACEUTICALS INC
ACETYLCYSTEINE, ACETYLCYSTEINE
AMINOCAPROIC ACID, AMINOCAPROIC ACID
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE
BUSULFAN, BUSULFAN
CAFFEINE CITRATE, CAFFEINE CITRATE
DROPERIDOL, DROPERIDOL
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
NITROGLYCERIN, NITROGLYCERIN
TRANEXAMIC ACID, TRANEXAMIC ACID
LUKARE MEDICAL LLC
* LUKARE MEDICAL LLC
 DECEMBER 2019 - APPROVED DRUG PRODUCT LIST B - 109