Drugs@FDA: FDA-Approved Drugs

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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 November 28, 2021.

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 HIKMA 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 EUGIA PHARMA 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 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 APPCO Approval
09/08/2021 BREXPIPRAZOLE
ANDA #213660
ORIG-1 BREXPIPRAZOLE ZYDUS PHARMS USA INC Tentative Approval
09/08/2021 HALCINONIDE
ANDA #214723
ORIG-1 HALCINONIDE GLASSHOUSE PHARMS Approval
09/08/2021 OBETICHOLIC
ANDA #214810
ORIG-1 OBETICHOLIC ACID AMNEAL PHARMS NY Tentative 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 MONISTAT 3
NDA #020827
SUPPL-33 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) 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 STRIDES PHARMA 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 GLYCOPYRROLATE
ANDA #213698
ORIG-1 GLYCOPYRROLATE GRACE CONSULTING SERVICES INC. Tentative Approval
09/15/2021 EXKIVITY
NDA #215310
ORIG-1 MOBOCERTINIB SUCCINATE 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
09/16/2021 GRALISE
NDA #022544
SUPPL-27 GABAPENTIN ALMATICA Manufacturing (CMC) 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 ALMATICA 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 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 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 PHOSPHATE 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 HIKMA Labeling Approval
09/22/2021 FAMOTIDINE
ANDA #075488
SUPPL-15 FAMOTIDINE HIKMA 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 ELUXADOLINE
ANDA #213576
ORIG-1 ELUXADOLINE MSN PHARMACEUTICALS INC Tentative 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 VANCOMYCIN HYDROCHLORIDE
ANDA #204125
SUPPL-11 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Labeling Approval
09/24/2021 ALUNBRIG
NDA #208772
SUPPL-12 BRIGATINIB TAKEDA PHARMS USA Labeling Approval
09/24/2021 TERIFLUNOMIDE
ANDA #209583
ORIG-1 TERIFLUNOMIDE BRECKENRIDGE 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
09/27/2021 HYCODAN
NDA #005213
SUPPL-44 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE GENUS Manufacturing (CMC) Approval
09/27/2021 ACETADOTE
NDA #021539
SUPPL-20 ACETYLCYSTEINE CUMBERLAND PHARMS Labeling Approval
09/27/2021 JAKAFI
NDA #202192
SUPPL-25 RUXOLITINIB PHOSPHATE INCYTE CORP Labeling Approval
09/27/2021 TASIMELTEON
ANDA #211601
ORIG-1 TASIMELTEON TEVA PHARMS USA INC Tentative Approval
09/27/2021 BREXPIPRAZOLE
ANDA #213782
ORIG-1 BREXPIPRAZOLE ALKEM LABS LTD Tentative Approval
09/27/2021 XOFLUZA
NDA #214410
SUPPL-1 BALOXAVIR MARBOXIL GENENTECH INC Labeling Approval
09/28/2021 CLOBAZAM
ANDA #209308
SUPPL-6 CLOBAZAM BRECKENRIDGE Labeling Approval
09/28/2021 MAVYRET
NDA #209394
SUPPL-14 GLECAPREVIR; PIBRENTASVIR ABBVIE INC Labeling Approval
09/28/2021 PROCHLORPERAZINE EDISYLATE
ANDA #213626
ORIG-1 PROCHLORPERAZINE EDISYLATE VIWIT PHARM Approval
09/28/2021 MAVYRET
NDA #215110
SUPPL-1 GLECAPREVIR; PIBRENTASVIR ABBVIE INC Labeling Approval
09/28/2021 QULIPTA
NDA #215206
ORIG-1 ATOGEPANT ABBVIE INC Type 1 - New Molecular Entity Approval
09/29/2021 ADDYI
NDA #022526
SUPPL-10 FLIBANSERIN SPROUT PHARMS Labeling Approval
09/29/2021 TADALAFIL
ANDA #200630
SUPPL-5 TADALAFIL MYLAN Labeling Approval
09/29/2021 DECITABINE
ANDA #202969
SUPPL-3 DECITABINE SANDOZ INC Labeling Approval
09/29/2021 DECITABINE
ANDA #202969
SUPPL-4 DECITABINE SANDOZ INC Labeling Approval
09/29/2021 DECITABINE
ANDA #202969
SUPPL-5 DECITABINE SANDOZ INC Labeling Approval
09/29/2021 DECITABINE
ANDA #203475
SUPPL-1 DECITABINE ACCORD HLTHCARE Labeling Approval
09/29/2021 DECITABINE
ANDA #203475
SUPPL-2 DECITABINE ACCORD HLTHCARE Labeling Approval
09/29/2021 DECITABINE
ANDA #203475
SUPPL-3 DECITABINE ACCORD HLTHCARE Labeling Approval
09/29/2021 BUDESONIDE
ANDA #206200
SUPPL-15 BUDESONIDE AMNEAL PHARMS Labeling Approval
09/29/2021 DALFAMPRIDINE
ANDA #206811
SUPPL-8 DALFAMPRIDINE AUROBINDO PHARMA LTD Labeling Approval
09/29/2021 CLOBAZAM
ANDA #209715
SUPPL-1 CLOBAZAM HIKMA Labeling Approval
09/29/2021 AMITRIPTYLINE HYDROCHLORIDE
ANDA #212654
SUPPL-1 AMITRIPTYLINE HYDROCHLORIDE UPSHER SMITH LABS Manufacturing (CMC) Approval
09/29/2021 METFORMIN HYDROCHLORIDE
ANDA #213247
ORIG-1 METFORMIN HYDROCHLORIDE TWI PHARMS Approval
09/29/2021 VIGABATRIN
ANDA #213899
ORIG-1 VIGABATRIN AUROBINDO PHARMA LTD Approval
09/29/2021 LIVMARLI
NDA #214662
ORIG-1 MARALIXIBAT CHLORIDE MIRUM Type 1 - New Molecular Entity Approval
09/29/2021 DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #214959
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ASCENT PHARMS INC Approval
09/30/2021 CLIMARA
NDA #020375
SUPPL-36 ESTRADIOL BAYER HLTHCARE Labeling Approval
09/30/2021 CLIMARA
NDA #020375
SUPPL-37 ESTRADIOL BAYER HLTHCARE Labeling Approval
09/30/2021 MENOSTAR
NDA #020375
SUPPL-36 ESTRADIOL BAYER HLTHCARE Labeling Approval
09/30/2021 MENOSTAR
NDA #020375
SUPPL-37 ESTRADIOL BAYER HLTHCARE Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #084610
SUPPL-41 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #084611
SUPPL-45 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #084612
SUPPL-32 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #084613
SUPPL-42 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #087916
SUPPL-29 DEXAMETHASONE HIKMA PHARMS Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #088248
SUPPL-26 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #088306
SUPPL-29 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 DEXAMETHASONE
ANDA #088316
SUPPL-25 DEXAMETHASONE HIKMA Labeling Approval
09/30/2021 TRULICITY
BLA #125469
SUPPL-44 DULAGLUTIDE ELI LILLY AND CO Approval
09/30/2021 HALAVEN
NDA #201532
SUPPL-21 ERIBULIN MESYLATE EISAI INC Labeling Approval
09/30/2021 RUBRACA
NDA #209115
SUPPL-9 RUCAPARIB CAMSYLATE CLOVIS ONCOLOGY INC Labeling Approval
09/30/2021 EPIDIOLEX
NDA #210365
SUPPL-12 CANNABIDIOL GW RES LTD Labeling Approval
09/30/2021 EPIDIOLEX
NDA #210365
SUPPL-13 CANNABIDIOL GW RES LTD Labeling Approval
09/30/2021 ZOLMITRIPTAN
ANDA #212469
ORIG-1 ZOLMITRIPTAN PADAGIS ISRAEL Approval
09/30/2021 CARBAMAZEPINE
ANDA #212948
ORIG-1 CARBAMAZEPINE ANBISON LAB Approval

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