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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 April 24, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/01/2021 ESTRADIOL
NDA #020538		 SUPPL-40 ESTRADIOL SANDOZ Labeling Approval
09/01/2021 VIVELLE-DOT
NDA #020538		 SUPPL-40 ESTRADIOL SANDOZ 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 PHARM HAINAN Labeling Approval
09/01/2021 ONDANSETRON HYDROCHLORIDE
ANDA #203711		 SUPPL-10 ONDANSETRON HYDROCHLORIDE QILU PHARM HAINAN Labeling 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
ANDA #077723		 SUPPL-31 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
09/02/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-31 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 DAPTOMYCIN
ANDA #213171		 ORIG-1 DAPTOMYCIN EUGIA PHARMA Approval
09/02/2021 TRUDHESA
NDA #213436		 ORIG-1 DIHYDROERGOTAMINE MESYLATE JN BIDCO Type 5 - New Formulation or New Manufacturer Approval
09/02/2021 ATORVASTATIN CALCIUM
ANDA #214969		 ORIG-1 ATORVASTATIN CALCIUM AGNITIO 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 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 US 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 ALEMBIC 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 MELPHALAN
ANDA #212810		 ORIG-1 MELPHALAN ALEMBIC GLOBAL Tentative 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 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 CHARTWELL MOLECULAR Labeling Approval
09/08/2021 ESCITALOPRAM OXALATE
ANDA #090477		 SUPPL-5 ESCITALOPRAM OXALATE CHARTWELL MOLECULAR Labeling Approval
09/08/2021 ESCITALOPRAM OXALATE
ANDA #090477		 SUPPL-6 ESCITALOPRAM OXALATE CHARTWELL MOLECULAR 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 RISING Labeling Approval
09/08/2021 LACTULOSE
ANDA #207786		 SUPPL-2 LACTULOSE APOZEAL PHARMS 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 CHARTWELL RX 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 STRIDES PHARMA 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 BPI LABS 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 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 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 EPIC PHARMA LLC Labeling Approval
09/13/2021 RIFAMPIN
ANDA #065390		 SUPPL-19 RIFAMPIN CHARTWELL MOLECULAR 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 CHARTWELL MOLECULAR Labeling Approval
09/13/2021 CITALOPRAM HYDROBROMIDE
ANDA #077629		 SUPPL-15 CITALOPRAM HYDROBROMIDE CHARTWELL MOLECULAR Labeling Approval
09/13/2021 CITALOPRAM HYDROBROMIDE
ANDA #077812		 SUPPL-14 CITALOPRAM HYDROBROMIDE AUROBINDO PHARMA 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 ANDA REPOSITORY 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 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 MSD SUB MERCK Efficacy Approval
09/17/2021 STEGLUJAN
NDA #209805		 SUPPL-8 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Efficacy Approval
09/17/2021 SEGLUROMET
NDA #209806		 SUPPL-6 ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE MSD SUB MERCK Efficacy 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 VIATRIS Labeling Approval
09/20/2021 PAXIL
NDA #020031		 SUPPL-79 PAROXETINE HYDROCHLORIDE APOTEX 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 Labeling Approval
09/20/2021 CELEXA
NDA #020822		 SUPPL-52 CITALOPRAM HYDROBROMIDE ABBVIE Labeling Approval
09/20/2021 PAXIL CR
NDA #020936		 SUPPL-60 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
09/20/2021 ZOLOFT
NDA #020990		 SUPPL-57 SERTRALINE HYDROCHLORIDE VIATRIS 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 ABBVIE Labeling Approval
09/20/2021 LEXAPRO
NDA #021365		 SUPPL-38 ESCITALOPRAM OXALATE ABBVIE 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 US Labeling Approval
09/20/2021 VIMPAT
NDA #022253		 SUPPL-53 LACOSAMIDE UCB INC Manufacturing (CMC) Approval
09/20/2021 SAVELLA
NDA #022256		 SUPPL-25 MILNACIPRAN HYDROCHLORIDE ABBVIE Labeling Approval
09/20/2021 VIIBRYD
NDA #022567		 SUPPL-22 VILAZODONE HYDROCHLORIDE ABBVIE Labeling Approval
09/20/2021 COLISTIMETHATE SODIUM
ANDA #065177		 SUPPL-15 COLISTIMETHATE SODIUM NEXUS 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 SAPTALIS PHARMS 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 RISING Labeling Approval
09/20/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076006		 SUPPL-9 FLUOXETINE HYDROCHLORIDE DR REDDYS 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 CHARTWELL RX Labeling Approval
09/20/2021 CITALOPRAM HYDROBROMIDE
ANDA #077812		 SUPPL-17 CITALOPRAM HYDROBROMIDE AUROBINDO PHARMA Labeling Approval
09/20/2021 FLUOXETINE HYDROCHLORIDE
ANDA #078045		 SUPPL-10 FLUOXETINE HYDROCHLORIDE NATCO PHARMA USA 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 TWI PHARMS 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 ABBVIE 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 Labeling Approval
09/20/2021 TYMLOS
NDA #208743		 SUPPL-9 ABALOPARATIDE RADIUS 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 PHARMOBEDIENT CNSLTG 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 BAJAJ 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 CHARTWELL MOLECULAR 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 CHARTWELL MOLECULAR 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 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 CHARTWELL MOLECULAR 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 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 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 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 SODIUM
ANDA #208315		 ORIG-1 MYCOPHENOLIC SODIUM 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 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 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 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 Labeling Approval
09/28/2021 QULIPTA
NDA #215206		 ORIG-1 ATOGEPANT ABBVIE 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 Labeling Approval
09/29/2021 DECITABINE
ANDA #202969		 SUPPL-4 DECITABINE SANDOZ Labeling Approval
09/29/2021 DECITABINE
ANDA #202969		 SUPPL-5 DECITABINE SANDOZ 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 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 AIPING PHARM INC 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 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #214959		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ASCENT PHARMS INC Approval
09/29/2021 INMAZEB
BLA #761169		 SUPPL-2 ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB REGENERON PHARMACEUTICALS 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 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 ZR PHARMA Labeling Approval
09/30/2021 EPIDIOLEX
NDA #210365		 SUPPL-12 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
09/30/2021 EPIDIOLEX
NDA #210365		 SUPPL-13 CANNABIDIOL JAZZ PHARMS RES 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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