Drugs@FDA: FDA-Approved Drugs

All Approvals and Tentative Approvals
September 2021

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on September 27, 2021.

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Approval Date	Drug Name	Submission	Active Ingredients	Company	Submission Classification *	Submission Status
09/01/2021	ESTRADIOL NDA #020538	SUPPL-40	ESTRADIOL	NOVARTIS	Labeling	Approval
09/01/2021	VIVELLE-DOT NDA #020538	SUPPL-40	ESTRADIOL	NOVARTIS	Labeling	Approval
09/01/2021	OPTISON NDA #020899	SUPPL-23	ALBUMIN HUMAN	GE HEALTHCARE	Labeling	Approval
09/01/2021	ZYVOX NDA #021130	SUPPL-42	LINEZOLID	PFIZER	Labeling	Approval
09/01/2021	ZYVOX NDA #021131	SUPPL-38	LINEZOLID	PFIZER	Labeling	Approval
09/01/2021	ZYVOX NDA #021132	SUPPL-41	LINEZOLID	PFIZER	Labeling	Approval
09/01/2021	ONDANSETRON HYDROCHLORIDE ANDA #077473	SUPPL-10	ONDANSETRON HYDROCHLORIDE	HOSPIRA	Labeling	Approval
09/01/2021	ONDANSETRON HYDROCHLORIDE ANDA #077473	SUPPL-13	ONDANSETRON HYDROCHLORIDE	HOSPIRA	Labeling	Approval
09/01/2021	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #077548	SUPPL-11	ONDANSETRON HYDROCHLORIDE	HOSPIRA	Labeling	Approval
09/01/2021	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #077548	SUPPL-14	ONDANSETRON HYDROCHLORIDE	HOSPIRA	Labeling	Approval
09/01/2021	FLUOXETINE HYDROCHLORIDE ANDA #078572	SUPPL-7	FLUOXETINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
09/01/2021	FLUOXETINE HYDROCHLORIDE ANDA #078572	SUPPL-8	FLUOXETINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
09/01/2021	FLUOXETINE HYDROCHLORIDE ANDA #078572	SUPPL-9	FLUOXETINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
09/01/2021	IRBESARTAN ANDA #203081	SUPPL-18	IRBESARTAN	AUROBINDO PHARMA LTD	Labeling	Approval
09/01/2021	ONDANSETRON HYDROCHLORIDE ANDA #203711	SUPPL-2	ONDANSETRON HYDROCHLORIDE	QILU	Labeling	Approval
09/01/2021	ONDANSETRON HYDROCHLORIDE ANDA #203711	SUPPL-10	ONDANSETRON HYDROCHLORIDE	QILU	Labeling	Approval
09/01/2021	MACITENTAN ANDA #211195	ORIG-1	MACITENTAN	APOTEX INC		Tentative Approval
09/02/2021	LOESTRIN 24 FE NDA #021871	SUPPL-10	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TEVA BRANDED PHARM	Labeling	Approval
09/02/2021	DIAZEPAM ANDA #071308	SUPPL-8	DIAZEPAM	WEST-WARD PHARMS INT	Labeling	Approval
09/02/2021	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077723	SUPPL-31	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
09/02/2021	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077727	SUPPL-28	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
09/02/2021	VENLAFAXINE HYDROCHLORIDE ANDA #078627	SUPPL-12	VENLAFAXINE HYDROCHLORIDE	SUN PHARM INDS INC	Labeling	Approval
09/02/2021	BRIVIACT NDA #205836	SUPPL-11	BRIVARACETAM	UCB INC	Labeling	Approval
09/02/2021	BRIVIACT NDA #205837	SUPPL-9	BRIVARACETAM	UCB INC	Labeling	Approval
09/02/2021	BRIVIACT NDA #205838	SUPPL-8	BRIVARACETAM	UCB INC	Labeling	Approval
09/02/2021	FLUOXETINE HYDROCHLORIDE ANDA #206937	SUPPL-3	FLUOXETINE HYDROCHLORIDE	TORRENT	Labeling	Approval
09/02/2021	SITAGLIPTIN NDA #211566	ORIG-1	SITAGLIPTIN	ZYDUS WORLDWIDE DMCC	Type 2 - New Active Ingredient	Tentative Approval
09/02/2021	DAPTOMYCIN ANDA #213171	ORIG-1	DAPTOMYCIN	AUROBINDO PHARMA LTD		Approval
09/02/2021	TRUDHESA NDA #213436	ORIG-1	DIHYDROERGOTAMINE MESYLATE	IMPEL NEUROPHARMA	Type 5 - New Formulation or New Manufacturer	Approval
09/02/2021	ATORVASTATIN CALCIUM ANDA #214969	ORIG-1	ATORVASTATIN CALCIUM	AUGUST		Approval
09/02/2021	HEMLIBRA BLA #761083	SUPPL-11	EMICIZUMAB	GENENTECH INC		Approval
09/03/2021	OLANZAPINE ANDA #076534	SUPPL-5	OLANZAPINE	DR REDDYS LABS LTD	Labeling	Approval
09/03/2021	OLANZAPINE ANDA #076534	SUPPL-6	OLANZAPINE	DR REDDYS LABS LTD	Labeling	Approval
09/03/2021	OLANZAPINE ANDA #076534	SUPPL-7	OLANZAPINE	DR REDDYS LABS LTD	Labeling	Approval
09/03/2021	OLANZAPINE ANDA #076534	SUPPL-8	OLANZAPINE	DR REDDYS LABS LTD	Labeling	Approval
09/03/2021	OLANZAPINE ANDA #076534	SUPPL-9	OLANZAPINE	DR REDDYS LABS LTD	Labeling	Approval
09/03/2021	OLANZAPINE ANDA #076534	SUPPL-10	OLANZAPINE	DR REDDYS LABS LTD	Manufacturing (CMC)	Approval
09/03/2021	CITALOPRAM HYDROBROMIDE ANDA #077043	SUPPL-15	CITALOPRAM HYDROBROMIDE	HIKMA PHARMS	Labeling	Approval
09/03/2021	VENLAFAXINE HYDROCHLORIDE ANDA #078554	SUPPL-8	VENLAFAXINE HYDROCHLORIDE	HERITAGE PHARMS INC	Labeling	Approval
09/03/2021	LATANOPROST ANDA #201006	SUPPL-13	LATANOPROST	BAUSCH AND LOMB	Labeling	Approval
09/03/2021	ESCITALOPRAM OXALATE ANDA #202227	SUPPL-5	ESCITALOPRAM OXALATE	AMNEAL PHARMS	Labeling	Approval
09/03/2021	ESCITALOPRAM OXALATE ANDA #202227	SUPPL-6	ESCITALOPRAM OXALATE	AMNEAL PHARMS	Labeling	Approval
09/03/2021	ESCITALOPRAM OXALATE ANDA #202227	SUPPL-10	ESCITALOPRAM OXALATE	AMNEAL PHARMS	Labeling	Approval
09/03/2021	ESCITALOPRAM OXALATE ANDA #202754	SUPPL-1	ESCITALOPRAM OXALATE	MACLEODS PHARMS LTD	Labeling	Approval
09/03/2021	ESCITALOPRAM OXALATE ANDA #202754	SUPPL-5	ESCITALOPRAM OXALATE	MACLEODS PHARMS LTD	Labeling	Approval
09/03/2021	RAVICTI NDA #203284	SUPPL-12	GLYCEROL PHENYLBUTYRATE	HORIZON THERAP	Labeling	Approval
09/03/2021	VENLAFAXINE HYDROCHLORIDE ANDA #206250	SUPPL-1	VENLAFAXINE HYDROCHLORIDE	CADILA PHARMS LTD	Labeling	Approval
09/03/2021	ALECENSA NDA #208434	SUPPL-12	ALECTINIB HYDROCHLORIDE	HOFFMANN-LA ROCHE	Labeling	Approval
09/03/2021	TESTOSTERONE ANDA #209836	ORIG-1	TESTOSTERONE	TWI PHARMS		Approval
09/03/2021	METRONIDAZOLE ANDA #212646	ORIG-1	METRONIDAZOLE	ALEOR DERMACEUTICALS		Approval
09/03/2021	CHLOROQUINE PHOSPHATE ANDA #214756	ORIG-1	CHLOROQUINE PHOSPHATE	SUVEN PHARMS		Approval
09/03/2021	DEXMEDETOMIDINE HYDROCHLORIDE ANDA #214794	ORIG-1	DEXMEDETOMIDINE HYDROCHLORIDE	PIRAMAL CRITICAL		Approval
09/03/2021	PAROXETINE HYDROCHLORIDE ANDA #215003	ORIG-1	PAROXETINE HYDROCHLORIDE	NOVITIUM PHARMA		Approval
09/07/2021	FORTEO NDA #021318	SUPPL-56	TERIPARATIDE	LILLY	Labeling	Approval
09/07/2021	NEXTERONE NDA #022325	SUPPL-16	AMIODARONE HYDROCHLORIDE	BAXTER HLTHCARE	Labeling	Approval
09/07/2021	FLUOXETINE HYDROCHLORIDE ANDA #077849	SUPPL-11	FLUOXETINE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
09/07/2021	FLUOXETINE HYDROCHLORIDE ANDA #077849	SUPPL-12	FLUOXETINE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
09/07/2021	ESCITALOPRAM OXALATE ANDA #079062	SUPPL-9	ESCITALOPRAM OXALATE	AUROBINDO PHARMA LTD	Labeling	Approval
09/07/2021	ESCITALOPRAM OXALATE ANDA #079062	SUPPL-11	ESCITALOPRAM OXALATE	AUROBINDO PHARMA LTD	Labeling	Approval
09/07/2021	ESCITALOPRAM OXALATE ANDA #079062	SUPPL-14	ESCITALOPRAM OXALATE	AUROBINDO PHARMA LTD	Labeling	Approval
09/07/2021	ESCITALOPRAM OXALATE ANDA #079062	SUPPL-15	ESCITALOPRAM OXALATE	AUROBINDO PHARMA LTD	Labeling	Approval
09/07/2021	ERLEADA NDA #210951	SUPPL-6	APALUTAMIDE	JANSSEN BIOTECH	Efficacy	Approval
09/07/2021	EPTIFIBATIDE ANDA #213081	ORIG-1	EPTIFIBATIDE	SHUANGCHENG		Approval
09/07/2021	AMPHETAMINE SULFATE ANDA #213852	ORIG-1	AMPHETAMINE SULFATE	RHODES PHARMS		Approval
09/07/2021	ESOMEPRAZOLE MAGNESIUM NDA #214278	SUPPL-1	ESOMEPRAZOLE MAGNESIUM	DEXCEL PHARMA	Labeling	Approval
09/07/2021	LABETALOL HYDROCHLORIDE ANDA #214533	ORIG-1	LABETALOL HYDROCHLORIDE	CAPLIN		Approval
09/08/2021	ESCITALOPRAM OXALATE ANDA #079121	SUPPL-8	ESCITALOPRAM OXALATE	TARO	Labeling	Approval
09/08/2021	ESCITALOPRAM OXALATE ANDA #079121	SUPPL-9	ESCITALOPRAM OXALATE	TARO	Labeling	Approval
09/08/2021	ESCITALOPRAM OXALATE ANDA #079121	SUPPL-10	ESCITALOPRAM OXALATE	TARO	Labeling	Approval
09/08/2021	ESCITALOPRAM OXALATE ANDA #090477	SUPPL-4	ESCITALOPRAM OXALATE	LANNETT CO INC	Labeling	Approval
09/08/2021	ESCITALOPRAM OXALATE ANDA #090477	SUPPL-5	ESCITALOPRAM OXALATE	LANNETT CO INC	Labeling	Approval
09/08/2021	ESCITALOPRAM OXALATE ANDA #090477	SUPPL-6	ESCITALOPRAM OXALATE	LANNETT CO INC	Labeling	Approval
09/08/2021	RILUZOLE ANDA #091300	SUPPL-1	RILUZOLE	APOTEX CORP	Labeling	Approval
09/08/2021	RILUZOLE ANDA #091300	SUPPL-4	RILUZOLE	APOTEX CORP	Labeling	Approval
09/08/2021	RILUZOLE ANDA #203042	SUPPL-1	RILUZOLE	MYLAN PHARMS INC	Labeling	Approval
09/08/2021	RILUZOLE ANDA #203042	SUPPL-3	RILUZOLE	MYLAN PHARMS INC	Labeling	Approval
09/08/2021	DALFAMPRIDINE ANDA #206836	SUPPL-2	DALFAMPRIDINE	ACTAVIS LABS FL INC	Labeling	Approval
09/08/2021	DALFAMPRIDINE ANDA #206858	SUPPL-1	DALFAMPRIDINE	MYLAN	Labeling	Approval
09/08/2021	LACTULOSE ANDA #207786	SUPPL-2	LACTULOSE	TORRENT	Manufacturing (CMC)	Approval
09/08/2021	DALFAMPRIDINE ANDA #208292	SUPPL-4	DALFAMPRIDINE	SUN PHARM	Labeling	Approval
09/08/2021	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE ANDA #208475	ORIG-1	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	B BRAUN MEDICAL INC		Approval
09/08/2021	ELIGLUSTAT TARTRATE ANDA #212463	ORIG-1	ELIGLUSTAT TARTRATE	AIZANT		Approval
09/08/2021	HALCINONIDE ANDA #214723	ORIG-1	HALCINONIDE	GLASSHOUSE PHARMS		Approval
09/09/2021	GABAPENTIN ANDA #078926	SUPPL-18	GABAPENTIN	ZYDUS PHARMS USA INC	Labeling	Approval
09/09/2021	TYBOST NDA #203094	SUPPL-16	COBICISTAT	GILEAD SCIENCES INC	Labeling	Approval
09/09/2021	STRIBILD NDA #203100	SUPPL-36	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
09/09/2021	TALZENNA NDA #211651	SUPPL-7	TALAZOPARIB TOSYLATE	PFIZER	Efficacy	Approval
09/09/2021	CYCLOPHOSPHAMIDE NDA #212501	SUPPL-2	CYCLOPHOSPHAMIDE	INGENUS PHARMS LLC	Labeling	Approval
09/09/2021	AVSOLA BLA #761086	SUPPL-1	INFLIXIMAB-AXXQ	AMGEN INC		Approval
09/10/2021	ULTRAM NDA #020281	SUPPL-49	TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
09/10/2021	AVAPRO NDA #020757	SUPPL-74	IRBESARTAN	SANOFI AVENTIS US	Labeling	Approval
09/10/2021	AVALIDE NDA #020758	SUPPL-80	HYDROCHLOROTHIAZIDE; IRBESARTAN	SANOFI AVENTIS US	Labeling	Approval
09/10/2021	ULTRACET NDA #021123	SUPPL-21	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
09/10/2021	CONZIP NDA #022370	SUPPL-23	TRAMADOL HYDROCHLORIDE	CIPHER PHARMS INC	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #078783	SUPPL-13	TRAMADOL HYDROCHLORIDE	PAR PHARM INC	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #091607	SUPPL-26	TRAMADOL HYDROCHLORIDE	SUN PHARM	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #091609	SUPPL-11	TRAMADOL HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #200491	SUPPL-16	TRAMADOL HYDROCHLORIDE	ANCHEN PHARMS	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #200503	SUPPL-12	TRAMADOL HYDROCHLORIDE	LUPIN LTD	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #201384	SUPPL-23	TRAMADOL HYDROCHLORIDE	SUN PHARM	Labeling	Approval
09/10/2021	ADEMPAS NDA #204819	SUPPL-15	RIOCIGUAT	BAYER HLTHCARE	Labeling	Approval
09/10/2021	EPINEPHRINE NDA #205029	SUPPL-6	EPINEPHRINE	BELCHER	Labeling	Approval
09/10/2021	TRAMADOL HYDROCHLORIDE ANDA #205257	SUPPL-10	TRAMADOL HYDROCHLORIDE	MYLAN	Labeling	Approval
09/10/2021	ODEFSEY NDA #208351	SUPPL-13	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
09/10/2021	MAYZENT NDA #209884	SUPPL-5	SIPONIMOD FUMARIC ACID	NOVARTIS	Labeling	Approval
09/10/2021	BIKTARVY NDA #210251	SUPPL-13	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
09/10/2021	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE ANDA #213484	ORIG-1	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	BIONPHARMA INC		Approval
09/10/2021	QDOLO NDA #214044	SUPPL-1	TRAMADOL HYDROCHLORIDE	ATHENA	Labeling	Approval
09/12/2021	FLUOXETINE HYDROCHLORIDE ANDA #075292	SUPPL-20	FLUOXETINE HYDROCHLORIDE	NOSTRUM LABS INC	Labeling	Approval
09/13/2021	METHADOSE NDA #017116	SUPPL-43	METHADONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/13/2021	RIFAMPIN ANDA #064150	SUPPL-35	RIFAMPIN	SANDOZ	Labeling	Approval
09/13/2021	RIFAMPIN ANDA #065390	SUPPL-19	RIFAMPIN	LANNETT CO INC	Labeling	Approval
09/13/2021	CITALOPRAM HYDROBROMIDE ANDA #077601	SUPPL-7	CITALOPRAM HYDROBROMIDE	PHARM ASSOC	Labeling	Approval
09/13/2021	CITALOPRAM HYDROBROMIDE ANDA #077629	SUPPL-14	CITALOPRAM HYDROBROMIDE	LANNETT CO INC	Labeling	Approval
09/13/2021	CITALOPRAM HYDROBROMIDE ANDA #077629	SUPPL-15	CITALOPRAM HYDROBROMIDE	LANNETT CO INC	Labeling	Approval
09/13/2021	CITALOPRAM HYDROBROMIDE ANDA #077812	SUPPL-14	CITALOPRAM HYDROBROMIDE	AUROBINDO PHARMA LTD	Labeling	Approval
09/13/2021	CITALOPRAM HYDROBROMIDE ANDA #201450	SUPPL-1	CITALOPRAM HYDROBROMIDE	HETERO LABS LTD III	Labeling	Approval
09/13/2021	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE ANDA #204287	ORIG-1	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	MACLEODS PHARMS LTD		Approval
09/13/2021	GENVOYA NDA #207561	SUPPL-27	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
09/13/2021	EPHEDRINE SULFATE ANDA #209646	SUPPL-1	EPHEDRINE SULFATE	FRESENIUS KABI USA	Manufacturing (CMC)	Approval
09/13/2021	IBUPROFEN ANDA #214699	ORIG-1	IBUPROFEN	ALKEM LABS LTD		Approval
09/14/2021	INFED NDA #017441	SUPPL-180	FERRIC OXYHYDROXIDE	ALLERGAN	Labeling	Approval
09/14/2021	METHOTREXATE PRESERVATIVE FREE ANDA #040266	SUPPL-12	METHOTREXATE SODIUM	FRESENIUS KABI USA	Labeling	Approval
09/14/2021	METHOTREXATE PRESERVATIVE FREE ANDA #040266	SUPPL-16	METHOTREXATE SODIUM	FRESENIUS KABI USA	Labeling	Approval
09/14/2021	RABEPRAZOLE SODIUM ANDA #076822	SUPPL-13	RABEPRAZOLE SODIUM	TEVA PHARMS USA	Labeling	Approval
09/14/2021	MECLIZINE HYDROCHLORIDE ANDA #084657	SUPPL-54	MECLIZINE HYDROCHLORIDE	ANI PHARMS	Manufacturing (CMC)	Approval
09/14/2021	RIFAMPIN ANDA #090034	SUPPL-15	RIFAMPIN	LUPIN PHARMS	Labeling	Approval
09/14/2021	IRBESARTAN ANDA #201531	SUPPL-10	IRBESARTAN	LUPIN LTD	Labeling	Approval
09/14/2021	IRBESARTAN ANDA #201531	SUPPL-11	IRBESARTAN	LUPIN LTD	Labeling	Approval
09/14/2021	HYDROXYCHLOROQUINE SULFATE ANDA #201691	SUPPL-6	HYDROXYCHLOROQUINE SULFATE	ALKALOIDA ZRT	Labeling	Approval
09/14/2021	RABEPRAZOLE SODIUM ANDA #202376	SUPPL-17	RABEPRAZOLE SODIUM	TORRENT	Labeling	Approval
09/14/2021	RABEPRAZOLE SODIUM ANDA #208644	SUPPL-10	RABEPRAZOLE SODIUM	ALKEM LABS LTD	Labeling	Approval
09/14/2021	CHOLESTYRAMINE ANDA #211119	SUPPL-6	CHOLESTYRAMINE	AJANTA PHARMA LTD	Labeling	Approval
09/14/2021	BRUKINSA NDA #213217	SUPPL-5	ZANUBRUTINIB	BEIGENE	Efficacy	Approval
09/15/2021	VIMPAT NDA #022253	SUPPL-51	LACOSAMIDE	UCB INC	Labeling	Approval
09/15/2021	VIMPAT NDA #022254	SUPPL-41	LACOSAMIDE	UCB INC	Labeling	Approval
09/15/2021	VIMPAT NDA #022255	SUPPL-33	LACOSAMIDE	UCB INC	Labeling	Approval
09/15/2021	MYCOBUTIN NDA #050689	SUPPL-26	RIFABUTIN	PFIZER	Labeling	Approval
09/15/2021	CEFUROXIME AXETIL ANDA #065359	SUPPL-10	CEFUROXIME AXETIL	ORCHID HLTHCARE	Labeling	Approval
09/15/2021	ALPRAZOLAM ANDA #074112	SUPPL-36	ALPRAZOLAM	SANDOZ	Labeling	Approval
09/15/2021	OXYBUTYNIN CHLORIDE ANDA #075079	SUPPL-21	OXYBUTYNIN CHLORIDE	VINTAGE PHARMS	Manufacturing (CMC)	Approval
09/15/2021	RIVASTIGMINE TARTRATE ANDA #077129	SUPPL-4	RIVASTIGMINE TARTRATE	WATSON LABS	Labeling	Approval
09/15/2021	RIVASTIGMINE TARTRATE ANDA #077129	SUPPL-5	RIVASTIGMINE TARTRATE	WATSON LABS	Labeling	Approval
09/15/2021	TAMSULOSIN HYDROCHLORIDE ANDA #078015	SUPPL-13	TAMSULOSIN HYDROCHLORIDE	SANDOZ	Manufacturing (CMC)	Approval
09/15/2021	TAMSULOSIN HYDROCHLORIDE ANDA #078015	SUPPL-14	TAMSULOSIN HYDROCHLORIDE	SANDOZ	Labeling	Approval
09/15/2021	METOPROLOL TARTRATE ANDA #091045	SUPPL-3	METOPROLOL TARTRATE	FRESENIUS KABI USA	Labeling	Approval
09/15/2021	CLOPIDOGREL BISULFATE ANDA #202928	SUPPL-26	CLOPIDOGREL BISULFATE	MACLEODS PHARMS LTD	Labeling	Approval
09/15/2021	IRBESARTAN ANDA #203071	SUPPL-7	IRBESARTAN	PRINSTON INC	Labeling	Approval
09/15/2021	IRBESARTAN ANDA #203071	SUPPL-8	IRBESARTAN	PRINSTON INC	Labeling	Approval
09/15/2021	DALFAMPRIDINE ANDA #206765	SUPPL-6	DALFAMPRIDINE	ALKEM LABS LTD	Labeling	Approval
09/15/2021	DALFAMPRIDINE ANDA #206765	SUPPL-7	DALFAMPRIDINE	ALKEM LABS LTD	Labeling	Approval
09/15/2021	DESCOVY NDA #208215	SUPPL-19	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
09/15/2021	VEMLIDY NDA #208464	SUPPL-13	TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
09/15/2021	EZETIMIBE AND SIMVASTATIN ANDA #208831	SUPPL-6	EZETIMIBE; SIMVASTATIN	AMNEAL PHARMS CO	Labeling	Approval
09/15/2021	KISQALI NDA #209092	SUPPL-9	RIBOCICLIB SUCCINATE	NOVARTIS	Labeling	Approval
09/15/2021	KISQALI FEMARA CO-PACK (COPACKAGED) NDA #209935	SUPPL-13	LETROZOLE; RIBOCICLIB SUCCINATE	NOVARTIS	Labeling	Approval
09/15/2021	DALFAMPRIDINE ANDA #210158	SUPPL-4	DALFAMPRIDINE	MICRO LABS	Labeling	Approval
09/15/2021	EXKIVITY NDA #215310	ORIG-1	MOBOCERTINIB	TAKEDA PHARMS USA	Type 1 - New Molecular Entity	Approval
09/16/2021	CLIMARA NDA #020375	SUPPL-45	ESTRADIOL	BAYER HLTHCARE	Labeling	Approval
09/16/2021	CLIMARA NDA #020375	SUPPL-46	ESTRADIOL	BAYER HLTHCARE	Labeling	Approval
09/16/2021	MENOSTAR NDA #020375	SUPPL-45	ESTRADIOL	BAYER HLTHCARE	Labeling	Approval
09/16/2021	MENOSTAR NDA #020375	SUPPL-46	ESTRADIOL	BAYER HLTHCARE	Labeling	Approval
09/16/2021	OPTISON NDA #020899	SUPPL-24	ALBUMIN HUMAN	GE HEALTHCARE	Labeling	Approval
09/17/2021	CABOMETYX NDA #208692	SUPPL-12	CABOZANTINIB S-MALATE	EXELIXIS INC	Efficacy	Approval
09/17/2021	STEGLATRO NDA #209803	SUPPL-4	ERTUGLIFLOZIN	MERCK SHARP DOHME	Efficacy	Approval
09/17/2021	STEGLUJAN NDA #209805	SUPPL-8	ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE	MERCK SHARP DOHME	Efficacy	Approval
09/17/2021	SEGLUROMET NDA #209806	SUPPL-6	ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE	MERCK SHARP DOHME	Efficacy	Approval
09/17/2021	VORTIOXETINE HYDROBROMIDE ANDA #211146	ORIG-1	VORTIOXETINE HYDROBROMIDE	ZYDUS PHARMS		Approval
09/17/2021	QUINIDINE GLUCONATE ANDA #212589	ORIG-1	QUINIDINE GLUCONATE	EYWA		Approval
09/17/2021	ACETAMINOPHEN ANDA #214331	ORIG-1	ACETAMINOPHEN	BAXTER HLTHCARE CORP		Approval
09/17/2021	BYOOVIZ BLA #761202	ORIG-1	RANIBIZUMAB-NUNA	SAMSUNG BIOEPIS CO LTD		Approval
09/20/2021	ZOLOFT NDA #019839	SUPPL-100	SERTRALINE HYDROCHLORIDE	UPJOHN	Labeling	Approval
09/20/2021	PAXIL NDA #020031	SUPPL-79	PAROXETINE HYDROCHLORIDE	APOTEX TECHNOLOGIES	Labeling	Approval
09/20/2021	EFFEXOR XR NDA #020699	SUPPL-114	VENLAFAXINE HYDROCHLORIDE	UPJOHN	Labeling	Approval
09/20/2021	PAXIL NDA #020710	SUPPL-47	PAROXETINE HYDROCHLORIDE	APOTEX TECHNOLOGIES	Labeling	Approval
09/20/2021	CELEXA NDA #020822	SUPPL-52	CITALOPRAM HYDROBROMIDE	ALLERGAN	Labeling	Approval
09/20/2021	PAXIL CR NDA #020936	SUPPL-60	PAROXETINE HYDROCHLORIDE	APOTEX TECHNOLOGIES	Labeling	Approval
09/20/2021	ZOLOFT NDA #020990	SUPPL-57	SERTRALINE HYDROCHLORIDE	UPJOHN	Labeling	Approval
09/20/2021	PEXEVA NDA #021299	SUPPL-37	PAROXETINE MESYLATE	SEBELA IRELAND LTD	Labeling	Approval
09/20/2021	LEXAPRO NDA #021323	SUPPL-53	ESCITALOPRAM OXALATE	ALLERGAN	Labeling	Approval
09/20/2021	LEXAPRO NDA #021365	SUPPL-38	ESCITALOPRAM OXALATE	ALLERGAN	Labeling	Approval
09/20/2021	CYMBALTA NDA #021427	SUPPL-56	DULOXETINE HYDROCHLORIDE	LILLY	Labeling	Approval
09/20/2021	LUVOX NDA #021519	SUPPL-18	FLUVOXAMINE MALEATE	ANI PHARMS	Labeling	Approval
09/20/2021	SYMBYAX NDA #021520	SUPPL-54	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	LILLY	Labeling	Approval
09/20/2021	PREVANTICS MAXI SWABSTICK NDA #021524	SUPPL-24	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	PROF DSPLS	Labeling	Approval
09/20/2021	PREVANTICS SWAB NDA #021524	SUPPL-24	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	PROF DSPLS	Labeling	Approval
09/20/2021	PREVANTICS SWABSTICK NDA #021524	SUPPL-24	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	PROF DSPLS	Labeling	Approval
09/20/2021	SARAFEM NDA #021860	SUPPL-15	FLUOXETINE HYDROCHLORIDE	APIL	Labeling	Approval
09/20/2021	PRISTIQ NDA #021992	SUPPL-48	DESVENLAFAXINE SUCCINATE	PF PRISM CV	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE NDA #022104	SUPPL-21	VENLAFAXINE HYDROCHLORIDE	OSMOTICA PHARM	Labeling	Approval
09/20/2021	SAVELLA NDA #022256	SUPPL-25	MILNACIPRAN HYDROCHLORIDE	ALLERGAN	Labeling	Approval
09/20/2021	VIIBRYD NDA #022567	SUPPL-22	VILAZODONE HYDROCHLORIDE	ALLERGAN	Labeling	Approval
09/20/2021	COLISTIMETHATE SODIUM ANDA #065177	SUPPL-15	COLISTIMETHATE SODIUM	NEXUS PHARMS	Labeling	Approval
09/20/2021	ALPRAZOLAM ANDA #074174	SUPPL-11	ALPRAZOLAM	NOVITIUM PHARMA	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #075292	SUPPL-21	FLUOXETINE HYDROCHLORIDE	NOSTRUM LABS INC	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #075525	SUPPL-6	FLUOXETINE HYDROCHLORIDE	AKORN	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #075690	SUPPL-8	FLUOXETINE HYDROCHLORIDE	ACTAVIS MID ATLANTIC	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #075755	SUPPL-26	FLUOXETINE HYDROCHLORIDE	MYLAN	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #076006	SUPPL-9	FLUOXETINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #076024	SUPPL-6	FLUOXETINE HYDROCHLORIDE	FOSUN PHARMA	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #076287	SUPPL-9	FLUOXETINE HYDROCHLORIDE	ANI PHARMS	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #077166	SUPPL-18	VENLAFAXINE HYDROCHLORIDE	MYLAN	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #077515	SUPPL-3	VENLAFAXINE HYDROCHLORIDE	FOSUN PHARMA	Labeling	Approval
09/20/2021	CITALOPRAM HYDROBROMIDE ANDA #077812	SUPPL-17	CITALOPRAM HYDROBROMIDE	AUROBINDO PHARMA LTD	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #078045	SUPPL-10	FLUOXETINE HYDROCHLORIDE	MYLAN	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #078301	SUPPL-9	VENLAFAXINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #078572	SUPPL-11	FLUOXETINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #078932	SUPPL-26	VENLAFAXINE HYDROCHLORIDE	ALEMBIC PHARMS LTD	Labeling	Approval
09/20/2021	ESCITALOPRAM OXALATE ANDA #079062	SUPPL-16	ESCITALOPRAM OXALATE	AUROBINDO PHARMA LTD	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #079098	SUPPL-13	VENLAFAXINE HYDROCHLORIDE	AMNEAL PHARMS	Labeling	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #090555	SUPPL-19	VENLAFAXINE HYDROCHLORIDE	AUROBINDO PHARMA	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE NDA #202133	SUPPL-12	FLUOXETINE HYDROCHLORIDE	ALVOGEN	Labeling	Approval
09/20/2021	ESCITALOPRAM OXALATE ANDA #202227	SUPPL-12	ESCITALOPRAM OXALATE	AMNEAL PHARMS	Labeling	Approval
09/20/2021	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE ANDA #203433	SUPPL-2	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	HIKMA PHARMS	Manufacturing (CMC)	Approval
09/20/2021	VANCOMYCIN HYDROCHLORIDE ANDA #204107	SUPPL-11	VANCOMYCIN HYDROCHLORIDE	XELLIA PHARMS APS	Labeling	Approval
09/20/2021	DESVENLAFAXINE NDA #204150	SUPPL-18	DESVENLAFAXINE	ALEMBIC PHARMS LTD	Labeling	Approval
09/20/2021	FETZIMA NDA #204168	SUPPL-7	LEVOMILNACIPRAN HYDROCHLORIDE	ALLERGAN	Labeling	Approval
09/20/2021	TRINTELLIX NDA #204447	SUPPL-24	VORTIOXETINE HYDROBROMIDE	TAKEDA PHARMS USA	Labeling	Approval
09/20/2021	BRISDELLE NDA #204516	SUPPL-11	PAROXETINE MESYLATE	SEBELA IRELAND LTD	Labeling	Approval
09/20/2021	KHEDEZLA NDA #204683	SUPPL-7	DESVENLAFAXINE	OSMOTICA PHARM CORP	Labeling	Approval
09/20/2021	BORTEZOMIB NDA #205004	SUPPL-3	BORTEZOMIB	FRESENIUS KABI USA	Efficacy	Approval
09/20/2021	VENLAFAXINE HYDROCHLORIDE ANDA #206250	SUPPL-2	VENLAFAXINE HYDROCHLORIDE	CADILA PHARMS LTD	Labeling	Approval
09/20/2021	CEFAZOLIN IN PLASTIC CONTAINER NDA #207131	SUPPL-8	CEFAZOLIN SODIUM	BAXTER HLTHCARE CORP	Labeling	Approval
09/20/2021	VERMOX NDA #208398	SUPPL-1	MEBENDAZOLE	JANSSEN PHARMS	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #208698	SUPPL-18	FLUOXETINE HYDROCHLORIDE	ALEMBIC PHARMS LTD	Labeling	Approval
09/20/2021	TYMLOS NDA #208743	SUPPL-9	ABALOPARATIDE	RADIUS HEALTH INC	Efficacy	Approval
09/20/2021	CLINDAMYCIN PHOSPHATE ANDA #210778	ORIG-1	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMS LTD		Approval
09/20/2021	TALZENNA NDA #211651	SUPPL-8	TALAZOPARIB TOSYLATE	PFIZER	Labeling	Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #211653	SUPPL-2	FLUOXETINE HYDROCHLORIDE	LUPIN LTD	Labeling	Approval
09/20/2021	FENOFIBRATE (MICRONIZED) ANDA #212232	ORIG-1	FENOFIBRATE	AUROBINDO PHARMA LTD		Approval
09/20/2021	FLUOXETINE HYDROCHLORIDE ANDA #213286	SUPPL-2	FLUOXETINE HYDROCHLORIDE	AUROBINDO PHARMA LTD	Labeling	Approval
09/20/2021	DECITABINE ANDA #214569	ORIG-1	DECITABINE	EUGIA PHARMA		Approval
09/20/2021	TIVDAK BLA #761208	ORIG-1	TISOTUMAB VEDOTIN-TFTV	SEAGEN		Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #075506	SUPPL-25	FLUOXETINE HYDROCHLORIDE	TEVA	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #075514	SUPPL-16	FLUOXETINE HYDROCHLORIDE	WOCKHARDT BIO AG	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #075872	SUPPL-32	FLUOXETINE HYDROCHLORIDE	TEVA	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #075920	SUPPL-18	FLUOXETINE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #076015	SUPPL-22	FLUOXETINE HYDROCHLORIDE	PHARM ASSOC	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #076458	SUPPL-10	FLUOXETINE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
09/21/2021	VENLAFAXINE HYDROCHLORIDE ANDA #076690	SUPPL-27	VENLAFAXINE HYDROCHLORIDE	TEVA	Labeling	Approval
09/21/2021	OXYCODONE HYDROCHLORIDE ANDA #076758	SUPPL-16	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/21/2021	OXYCODONE HYDROCHLORIDE ANDA #076758	SUPPL-18	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/21/2021	OXYCODONE HYDROCHLORIDE ANDA #076758	SUPPL-20	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/21/2021	OXYCODONE HYDROCHLORIDE ANDA #076758	SUPPL-22	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/21/2021	CITALOPRAM HYDROBROMIDE ANDA #077043	SUPPL-17	CITALOPRAM HYDROBROMIDE	HIKMA PHARMS	Labeling	Approval
09/21/2021	CITALOPRAM HYDROBROMIDE ANDA #077601	SUPPL-8	CITALOPRAM HYDROBROMIDE	PHARM ASSOC	Labeling	Approval
09/21/2021	CITALOPRAM HYDROBROMIDE ANDA #077629	SUPPL-16	CITALOPRAM HYDROBROMIDE	LANNETT CO INC	Labeling	Approval
09/21/2021	VENLAFAXINE HYDROCHLORIDE ANDA #077653	SUPPL-22	VENLAFAXINE HYDROCHLORIDE	ZYDUS PHARMS USA	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #077849	SUPPL-13	FLUOXETINE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
09/21/2021	VENLAFAXINE HYDROCHLORIDE ANDA #078554	SUPPL-10	VENLAFAXINE HYDROCHLORIDE	HERITAGE PHARMS INC	Labeling	Approval
09/21/2021	VENLAFAXINE HYDROCHLORIDE ANDA #078627	SUPPL-14	VENLAFAXINE HYDROCHLORIDE	SUN PHARM INDS INC	Labeling	Approval
09/21/2021	ESCITALOPRAM OXALATE ANDA #079121	SUPPL-11	ESCITALOPRAM OXALATE	TARO	Labeling	Approval
09/21/2021	VENLAFAXINE HYDROCHLORIDE ANDA #090027	SUPPL-15	VENLAFAXINE HYDROCHLORIDE	PRINSTON INC	Labeling	Approval
09/21/2021	ESCITALOPRAM OXALATE ANDA #090477	SUPPL-7	ESCITALOPRAM OXALATE	LANNETT CO INC	Labeling	Approval
09/21/2021	SELFEMRA ANDA #200151	SUPPL-7	FLUOXETINE HYDROCHLORIDE	TEVA PHARMS USA	Labeling	Approval
09/21/2021	FAMCICLOVIR ANDA #201333	SUPPL-2	FAMCICLOVIR	MYLAN	Labeling	Approval
09/21/2021	FAMCICLOVIR ANDA #201333	SUPPL-4	FAMCICLOVIR	MYLAN	Labeling	Approval
09/21/2021	FAMCICLOVIR ANDA #201333	SUPPL-5	FAMCICLOVIR	MYLAN	Labeling	Approval
09/21/2021	CITALOPRAM HYDROBROMIDE ANDA #201450	SUPPL-4	CITALOPRAM HYDROBROMIDE	HETERO LABS LTD III	Labeling	Approval
09/21/2021	VENLAFAXINE HYDROCHLORIDE ANDA #202036	SUPPL-6	VENLAFAXINE HYDROCHLORIDE	YAOPHARMA CO LTD	Labeling	Approval
09/21/2021	ESCITALOPRAM OXALATE ANDA #202221	SUPPL-6	ESCITALOPRAM OXALATE	HETERO LABS LTD III	Labeling	Approval
09/21/2021	ESCITALOPRAM OXALATE ANDA #202754	SUPPL-12	ESCITALOPRAM OXALATE	MACLEODS PHARMS LTD	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #203836	SUPPL-1	FLUOXETINE HYDROCHLORIDE	PAR FORM	Labeling	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #206937	SUPPL-6	FLUOXETINE HYDROCHLORIDE	TORRENT	Labeling	Approval
09/21/2021	METHYLPREDNISOLONE ANDA #207481	ORIG-1	METHYLPREDNISOLONE	AMNEAL		Approval
09/21/2021	CEFTAROLINE FOSAMIL ANDA #208075	ORIG-1	CEFTAROLINE FOSAMIL	APOTEX		Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #210935	SUPPL-4	FLUOXETINE HYDROCHLORIDE	SCIEGEN PHARMS INC	Labeling	Approval
09/21/2021	TALZENNA NDA #211651	SUPPL-9	TALAZOPARIB TOSYLATE	PFIZER	Manufacturing (CMC)	Approval
09/21/2021	FLUOXETINE HYDROCHLORIDE ANDA #211696	SUPPL-2	FLUOXETINE HYDROCHLORIDE	UPSHER SMITH LABS	Labeling	Approval
09/21/2021	APREMILAST ANDA #211761	ORIG-1	APREMILAST	ALKEM LABS LTD		Approval
09/21/2021	APREMILAST ANDA #211859	ORIG-1	APREMILAST	ZYDUS PHARMS		Approval
09/21/2021	ISOTRETINOIN ANDA #212333	ORIG-1	ISOTRETINOIN	UPSHER SMITH LABS		Approval
09/21/2021	OPZELURA NDA #215309	ORIG-1	RUXOLITINIB	INCYTE CORP	Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated	Approval
09/22/2021	VOTRIENT NDA #022465	SUPPL-31	PAZOPANIB HYDROCHLORIDE	NOVARTIS	Labeling	Approval
09/22/2021	VOTRIENT NDA #022465	SUPPL-32	PAZOPANIB HYDROCHLORIDE	NOVARTIS	Labeling	Approval
09/22/2021	CEFUROXIME AXETIL ANDA #065308	SUPPL-20	CEFUROXIME AXETIL	AUROBINDO PHARMA LTD	Labeling	Approval
09/22/2021	VINCRISTINE SULFATE PFS ANDA #071484	SUPPL-46	VINCRISTINE SULFATE	HOSPIRA	Labeling	Approval
09/22/2021	FAMOTIDINE PRESERVATIVE FREE ANDA #075486	SUPPL-17	FAMOTIDINE	WEST-WARD PHARMS INT	Labeling	Approval
09/22/2021	FAMOTIDINE ANDA #075488	SUPPL-15	FAMOTIDINE	WEST-WARD PHARMS INT	Labeling	Approval
09/22/2021	BACLOFEN ANDA #077241	SUPPL-21	BACLOFEN	LANNETT CO INC	Manufacturing (CMC)	Approval
09/22/2021	JAKAFI NDA #202192	SUPPL-23	RUXOLITINIB PHOSPHATE	INCYTE CORP	Efficacy	Approval
09/22/2021	XALKORI NDA #202570	SUPPL-31	CRIZOTINIB	PF PRISM CV	Labeling	Approval
09/22/2021	SUBLOCADE NDA #209819	SUPPL-19	BUPRENORPHINE	INDIVIOR INC	REMS	Approval
09/22/2021	COPIKTRA NDA #211155	SUPPL-3	DUVELISIB	SECURA	Labeling	Approval
09/22/2021	ESLICARBAZEPINE ACETATE ANDA #211247	ORIG-1	ESLICARBAZEPINE ACETATE	SPH SHANGHAI ZHONGXI PHARMA CO LTD		Tentative Approval
09/22/2021	PROCHLORPERAZINE EDISYLATE ANDA #214107	ORIG-1	PROCHLORPERAZINE EDISYLATE	GLAND PHARMA LTD		Approval
09/23/2021	TASIGNA NDA #022068	SUPPL-35	NILOTINIB HYDROCHLORIDE	NOVARTIS	Efficacy	Approval
09/23/2021	TASIGNA NDA #022068	SUPPL-36	NILOTINIB HYDROCHLORIDE	NOVARTIS	Efficacy	Approval
09/23/2021	SIRTURO NDA #204384	SUPPL-16	BEDAQUILINE FUMARATE	JANSSEN THERAP	Labeling	Approval
09/23/2021	MYCOPHENOLIC ACID ANDA #208315	ORIG-1	MYCOPHENOLIC ACID	ALKEM LABS LTD		Approval
09/23/2021	BRIMONIDINE TARTRATE ANDA #209158	ORIG-1	BRIMONIDINE TARTRATE	PADAGIS ISRAEL		Approval
09/23/2021	BUPRENORPHINE ANDA #210272	ORIG-1	BUPRENORPHINE	AVEVA		Approval
09/23/2021	VIGABATRIN ANDA #215109	ORIG-1	VIGABATRIN	DEXCEL PHARMA		Approval
09/24/2021	ERBITUX BLA #125084	SUPPL-279	CETUXIMAB	IMCLONE		Approval
09/24/2021	REPATHA BLA #125522	SUPPL-29	EVOLOCUMAB	AMGEN INC		Approval
09/24/2021	REPATHA BLA #125522	SUPPL-31	EVOLOCUMAB	AMGEN INC		Approval
09/24/2021	ALUNBRIG NDA #208772	SUPPL-12	BRIGATINIB	TAKEDA PHARMS USA	Labeling	Approval
09/24/2021	AJOVY BLA #761089	SUPPL-13	FREMANEZUMAB-VFRM	TEVA PHARMS USA		Approval
09/24/2021	VYEPTI BLA #761119	SUPPL-2	EPTINEZUMAB-JJMR	Lundbeck Seattle BioPharmaceuticals, Inc.		Approval

All Approvals and Tentative Approvals September 2021

All Approvals and Tentative Approvals
September 2021