Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
June 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 June 15, 2021.

 

< Previous Month     Next Month >
Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2021 NICARDIPINE HYDROCHLORIDE
NDA #022276		 SUPPL-18 NICARDIPINE HYDROCHLORIDE EXELA PHARMA SCIENCE Labeling Approval
06/01/2021 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA #022276		 SUPPL-18 NICARDIPINE HYDROCHLORIDE EXELA PHARMA SCIENCE Labeling Approval
06/01/2021 ALBUTEROL SULFATE
ANDA #207085		 ORIG-1 ALBUTEROL SULFATE SANDOZ INC Approval
06/01/2021 VYNDAQEL
NDA #211996		 SUPPL-1 TAFAMIDIS MEGLUMINE FOLDRX PHARMS Labeling Approval
06/01/2021 VYNDAMAX
NDA #212161		 SUPPL-1 TAFAMIDIS FOLDRX PHARMS Labeling Approval
06/01/2021 LIDOCAINE HYDROCHLORIDE
ANDA #212821		 SUPPL-1 LIDOCAINE HYDROCHLORIDE HUONS Manufacturing (CMC) Approval
06/01/2021 TOFACITINIB CITRATE
ANDA #212943		 ORIG-1 TOFACITINIB CITRATE AJANTA PHARMA LTD Approval
06/01/2021 TOFACITINIB CITRATE
ANDA #212943		 ORIG-2 TOFACITINIB CITRATE AJANTA PHARMA LTD Tentative Approval
06/01/2021 OSIMERTINIB MESYLATE
ANDA #214263		 ORIG-1 OSIMERTINIB MESYLATE ZYDUS PHARMS USA INC Tentative Approval
06/01/2021 BREXAFEMME
NDA #214900		 ORIG-1 IBREXAFUNGERP CITRATE SCYNEXIS Type 1 - New Molecular Entity Approval
06/02/2021 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-50 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
NDA #017058		 SUPPL-27 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
06/02/2021 METHADOSE
NDA #017116		 SUPPL-41 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
NDA #021624		 SUPPL-14 METHADONE HYDROCHLORIDE MYLAN INSTITUTIONAL Labeling Approval
06/02/2021 MORPHINE SULFATE
NDA #022195		 SUPPL-10 MORPHINE SULFATE HIKMA Efficacy Approval
06/02/2021 MORPHINE SULFATE
NDA #022207		 SUPPL-5 MORPHINE SULFATE HIKMA Efficacy Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-30 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-49 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-41 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #088108		 SUPPL-22 METHADONE HYDROCHLORIDE ROXANE Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #088109		 SUPPL-21 METHADONE HYDROCHLORIDE ROXANE Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-24 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
06/02/2021 RAXIBACUMAB
BLA #125349		 SUPPL-26 RAXIBACUMAB HUMAN GENOME SCIENCES INC. Approval
06/02/2021 GABAPENTIN
ANDA #202764		 SUPPL-6 GABAPENTIN INVAGEN PHARMS Labeling Approval
06/02/2021 GABAPENTIN
ANDA #202764		 SUPPL-7 GABAPENTIN INVAGEN PHARMS Labeling Approval
06/02/2021 GABAPENTIN
ANDA #202764		 SUPPL-8 GABAPENTIN INVAGEN PHARMS Labeling Approval
06/02/2021 GABAPENTIN
ANDA #202764		 SUPPL-21 GABAPENTIN INVAGEN PHARMS Labeling Approval
06/02/2021 GABAPENTIN
ANDA #202764		 SUPPL-24 GABAPENTIN INVAGEN PHARMS Labeling Approval
06/02/2021 GABAPENTIN
ANDA #202764		 SUPPL-25 GABAPENTIN INVAGEN PHARMS Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #203502		 SUPPL-8 METHADONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #204166		 SUPPL-1 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
06/02/2021 AKYNZEO
NDA #205718		 SUPPL-9 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
06/02/2021 MORPHINE SULFATE
ANDA #207270		 ORIG-1 MORPHINE SULFATE MAYNE PHARMA INC Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #207537		 SUPPL-3 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #208305		 SUPPL-5 METHADONE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #210484		 SUPPL-6 METHADONE HYDROCHLORIDE NOSTRUM LABS INC Labeling Approval
06/02/2021 AKYNZEO
NDA #210493		 SUPPL-4 FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
06/02/2021 METHADONE HYDROCHLORIDE
ANDA #211228		 SUPPL-2 METHADONE HYDROCHLORIDE ASCENT PHARMS INC Labeling Approval
06/02/2021 MICAFUNGIN SODIUM
ANDA #211713		 ORIG-1 MICAFUNGIN SODIUM XELLIA PHARMS APS Approval
06/02/2021 OXYCODONE HYDROCHLORIDE
ANDA #213761		 ORIG-1 OXYCODONE HYDROCHLORIDE QUAGEN Approval
06/02/2021 CHLORPROMAZINE HYDROCHLORIDE
ANDA #214542		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE GENUS Approval
06/02/2021 Monjuvi (tafasitamab-cxix) for injection
BLA #761163		 SUPPL-1 TAFASITAMAB-CXIX MORPHOSYS US INC Approval
06/03/2021 BETAPACE
NDA #019865		 SUPPL-22 SOTALOL HYDROCHLORIDE COVIS Labeling Approval
06/03/2021 TRIGLIDE
NDA #021350		 SUPPL-23 FENOFIBRATE SKYEPHARMA AG Labeling Approval
06/03/2021 LIPOFEN
NDA #021612		 SUPPL-24 FENOFIBRATE CIPHER PHARMS INC Labeling Approval
06/03/2021 TRICOR
NDA #021656		 SUPPL-30 FENOFIBRATE ABBVIE Labeling Approval
06/03/2021 TRICOR
NDA #021656		 SUPPL-31 FENOFIBRATE ABBVIE Labeling Approval
06/03/2021 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-22 FENOFIBRATE LUPIN Labeling Approval
06/03/2021 FENOGLIDE
NDA #022118		 SUPPL-13 FENOFIBRATE SALIX Labeling Approval
06/03/2021 TRILIPIX
NDA #022224		 SUPPL-16 CHOLINE FENOFIBRATE ABBVIE Labeling Approval
06/03/2021 TRILIPIX
NDA #022224		 SUPPL-17 CHOLINE FENOFIBRATE ABBVIE Labeling Approval
06/03/2021 FIBRICOR
NDA #022418		 SUPPL-19 FENOFIBRIC ACID ATHENA Labeling Approval
06/03/2021 DIAZEPAM
ANDA #070312		 SUPPL-17 DIAZEPAM WEST-WARD PHARMS INT Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #075753		 SUPPL-13 FENOFIBRATE RHODES PHARMS Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #075868		 SUPPL-23 FENOFIBRATE IMPAX LABS Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #076509		 SUPPL-34 FENOFIBRATE IMPAX LABS Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #076520		 SUPPL-21 FENOFIBRATE MYLAN Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #076635		 SUPPL-15 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #202676		 SUPPL-9 FENOFIBRATE MYLAN PHARMS INC Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #204019		 SUPPL-15 FENOFIBRATE LUPIN LTD Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #205566		 SUPPL-5 FENOFIBRATE GLENMARK PHARMS LTD Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #207378		 SUPPL-7 FENOFIBRATE INVAGEN PHARMS Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #207564		 SUPPL-2 FENOFIBRATE NOVAST LABS Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #207805		 SUPPL-16 FENOFIBRATE AUSTARPHARMA Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #209660		 SUPPL-3 FENOFIBRATE ALEMBIC LABS Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #209950		 SUPPL-4 FENOFIBRATE AMNEAL Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #210138		 SUPPL-18 FENOFIBRATE AJANTA PHARMA LTD Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #210606		 SUPPL-4 FENOFIBRATE GRAVITI PHARMS Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #210670		 SUPPL-4 FENOFIBRATE DR REDDYS Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #210705		 SUPPL-14 FENOFIBRATE AJANTA PHARMA LTD Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #210782		 SUPPL-3 FENOFIBRATE TORRENT Labeling Approval
06/03/2021 REYVOW
NDA #211280		 SUPPL-5 LASMIDITAN SUCCINATE ELI LILLY AND CO Labeling Approval
06/03/2021 THEOPHYLLINE
ANDA #212184		 ORIG-1 THEOPHYLLINE GLENMARK PHARMS LTD Approval
06/03/2021 ICATIBANT ACETATE
ANDA #212446		 SUPPL-1 ICATIBANT ACETATE CIPLA Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #213252		 SUPPL-3 FENOFIBRATE ALEMBIC PHARMS LTD Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #213842		 SUPPL-1 FENOFIBRATE ALEMBIC PHARMS LTD Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #213864		 SUPPL-6 FENOFIBRATE MANKIND PHARMA Labeling Approval
06/03/2021 IBRUTINIB
ANDA #214498		 ORIG-1 IBRUTINIB ALVOGEN INC Tentative Approval
06/04/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-32 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
06/04/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #065432		 SUPPL-28 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369		 SUPPL-10 HYDROCHLOROTHIAZIDE; IRBESARTAN TEVA Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369		 SUPPL-13 HYDROCHLOROTHIAZIDE; IRBESARTAN TEVA Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369		 SUPPL-17 HYDROCHLOROTHIAZIDE; IRBESARTAN TEVA Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369		 SUPPL-19 HYDROCHLOROTHIAZIDE; IRBESARTAN TEVA Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-11 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-12 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
06/04/2021 METHOTREXATE SODIUM
ANDA #081235		 SUPPL-30 METHOTREXATE SODIUM MYLAN Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-10 HYDROCHLOROTHIAZIDE; IRBESARTAN HIKMA Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-11 HYDROCHLOROTHIAZIDE; IRBESARTAN HIKMA Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091370		 SUPPL-23 HYDROCHLOROTHIAZIDE; IRBESARTAN ALEMBIC PHARMS LTD Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091370		 SUPPL-26 HYDROCHLOROTHIAZIDE; IRBESARTAN ALEMBIC PHARMS LTD Labeling Approval
06/04/2021 LOPINAVIR AND RITONAVIR
ANDA #091677		 ORIG-1 LOPINAVIR; RITONAVIR HETERO LABS LTD III Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-36 HYDROCHLOROTHIAZIDE; IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-43 HYDROCHLOROTHIAZIDE; IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
06/04/2021 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-36 IRBESARTAN: HYDROCHLOROTHIAZIDE MACLEODS PHARMS LTD Labeling Approval
06/04/2021 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-43 IRBESARTAN: HYDROCHLOROTHIAZIDE MACLEODS PHARMS LTD Labeling Approval
06/04/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #204131		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE LUPIN LTD Approval
06/04/2021 VALGANCICLOVIR HYDROCHLORIDE
ANDA #212234		 SUPPL-7 VALGANCICLOVIR HYDROCHLORIDE AJANTA PHARMA LTD Labeling Approval
06/04/2021 VALGANCICLOVIR HYDROCHLORIDE
ANDA #212234		 SUPPL-9 VALGANCICLOVIR HYDROCHLORIDE AJANTA PHARMA LTD Labeling Approval
06/04/2021 TRANEXAMIC ACID
ANDA #212360		 SUPPL-4 TRANEXAMIC ACID CAPLIN Labeling Approval
06/04/2021 TACROLIMUS
ANDA #213112		 SUPPL-1 TACROLIMUS CONCORD BIOTECH LTD Labeling Approval
06/04/2021 PANTOPRAZOLE SODIUM
ANDA #213725		 SUPPL-1 PANTOPRAZOLE SODIUM SUN PHARM Labeling Approval
06/04/2021 TEMBEXA
NDA #214460		 ORIG-1 BRINCIDOFOVIR CHIMERIX Type 2 - New Active Ingredient Approval
06/04/2021 TEMBEXA
NDA #214461		 ORIG-1 BRINCIDOFOVIR CHIMERIX Type 2 - New Active Ingredient Approval
06/04/2021 WEGOVY
NDA #215256		 ORIG-1 SEMAGLUTIDE NOVO Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
06/07/2021 HEPARIN SODIUM
NDA #017029		 SUPPL-159 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
06/07/2021 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029		 SUPPL-159 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
06/07/2021 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029		 SUPPL-159 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
06/07/2021 HEPARIN SODIUM
NDA #017651		 SUPPL-69 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
06/07/2021 MEDROXYPROGESTERONE ACETATE
ANDA #040159		 SUPPL-29 MEDROXYPROGESTERONE ACETATE BARR Labeling Approval
06/07/2021 PROPRANOLOL HYDROCHLORIDE
ANDA #070213		 SUPPL-36 PROPRANOLOL HYDROCHLORIDE MYLAN Labeling Approval
06/07/2021 THIOTHIXENE
ANDA #071093		 SUPPL-30 THIOTHIXENE MYLAN Labeling Approval
06/07/2021 TRAZODONE HYDROCHLORIDE
ANDA #073137		 SUPPL-41 TRAZODONE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
06/07/2021 TRAZODONE HYDROCHLORIDE
ANDA #073137		 SUPPL-42 TRAZODONE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
06/07/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-22 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
06/07/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-23 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
06/07/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-26 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
06/07/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-28 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
06/07/2021 ONDANSETRON HYDROCHLORIDE
ANDA #077544		 SUPPL-2 ONDANSETRON HYDROCHLORIDE PLIVA HRVATSKA DOO Labeling Approval
06/07/2021 ONDANSETRON HYDROCHLORIDE
ANDA #077544		 SUPPL-3 ONDANSETRON HYDROCHLORIDE PLIVA HRVATSKA DOO Labeling Approval
06/07/2021 PENNSAID
NDA #204623		 SUPPL-10 DICLOFENAC SODIUM HORIZON Labeling Approval
06/07/2021 OSELTAMIVIR PHOSPHATE
ANDA #210186		 SUPPL-1 OSELTAMIVIR PHOSPHATE AMNEAL PHARMS NY Labeling Approval
06/07/2021 OSELTAMIVIR PHOSPHATE
ANDA #210186		 SUPPL-5 OSELTAMIVIR PHOSPHATE AMNEAL PHARMS NY Labeling Approval
06/07/2021 OSELTAMIVIR PHOSPHATE
ANDA #210186		 SUPPL-7 OSELTAMIVIR PHOSPHATE AMNEAL PHARMS NY Labeling Approval
06/07/2021 BUSULFAN
ANDA #210931		 SUPPL-1 BUSULFAN SHILPA Labeling Approval
06/07/2021 ARGATROBAN
NDA #212035		 ORIG-1 ARGATROBAN ACCORD HLTHCARE INC Type 5 - New Formulation or New Manufacturer Approval
06/07/2021 DEXTROAMPHETAMINE SULFATE
ANDA #212160		 ORIG-1 DEXTROAMPHETAMINE SULFATE WINDER LABS LLC Approval
06/07/2021 UDENYCA
BLA #761039		 SUPPL-10 PEGFILGRASTIM-CBQV COHERUS BIOSCIENCES INC Approval
06/07/2021 ULTOMIRIS
BLA #761108		 SUPPL-12 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
06/07/2021 ADUHELM
BLA #761178		 ORIG-1 ADUCANUMAB-AVWA BIOGEN INC Approval
06/08/2021 MIRENA
NDA #021225		 SUPPL-36 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
06/08/2021 LETAIRIS
NDA #022081		 SUPPL-43 AMBRISENTAN GILEAD REMS Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-10 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-12 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-15 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-17 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-23 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-26 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-27 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
06/08/2021 LIGNOSPAN FORTE
ANDA #088389		 SUPPL-47 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Labeling Approval
06/08/2021 LIGNOSPAN STANDARD
ANDA #088390		 SUPPL-55 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Labeling Approval
06/08/2021 AMBRISENTAN
ANDA #208252		 SUPPL-4 AMBRISENTAN WATSON LABS INC REMS Approval
06/08/2021 AMBRISENTAN
ANDA #208354		 SUPPL-4 AMBRISENTAN SIGMAPHARM LABS LLC REMS Approval
06/08/2021 AMBRISENTAN
ANDA #208441		 SUPPL-3 AMBRISENTAN MYLAN REMS Approval
06/08/2021 AMBRISENTAN
ANDA #209509		 SUPPL-4 AMBRISENTAN PAR PHARM INC REMS Approval
06/08/2021 PERAMPANEL
ANDA #209801		 ORIG-1 PERAMPANEL TEVA PHARMS USA INC Approval
06/08/2021 PERAMPANEL
ANDA #209877		 ORIG-1 PERAMPANEL ACCORD HLTHCARE Approval
06/08/2021 AMBRISENTAN
ANDA #210058		 SUPPL-6 AMBRISENTAN ZYDUS PHARMS REMS Approval
06/08/2021 AMBRISENTAN
ANDA #210715		 SUPPL-6 AMBRISENTAN CIPLA REMS Approval
06/08/2021 AMBRISENTAN
ANDA #210784		 SUPPL-6 AMBRISENTAN SUN PHARM REMS Approval
06/08/2021 TRIKAFTA (COPACKAGED)
NDA #212273		 SUPPL-4 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR VERTEX PHARMS INC Efficacy Approval
06/09/2021 BETOPTIC S
NDA #019845		 SUPPL-30 BETAXOLOL HYDROCHLORIDE NOVARTIS Labeling Approval
06/09/2021 METADATE ER
ANDA #040306		 SUPPL-18 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
06/09/2021 METADATE ER
ANDA #040306		 SUPPL-19 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
06/09/2021 METOPROLOL TARTRATE
ANDA #074133		 SUPPL-36 METOPROLOL TARTRATE HOSPIRA Labeling Approval
06/09/2021 METOPROLOL TARTRATE
ANDA #075160		 SUPPL-21 METOPROLOL TARTRATE HOSPIRA Labeling Approval
06/09/2021 MYALEPT
BLA #125390		 SUPPL-23 METRELEPTIN AEGERION Approval
06/09/2021 FLUDEOXYGLUCOSE F18
ANDA #203246		 SUPPL-4 FLUDEOXYGLUCOSE F-18 UNIV TX MD ANDERSON Labeling Approval
06/09/2021 IZBA
NDA #204822		 SUPPL-2 TRAVOPROST NOVARTIS Labeling Approval
06/10/2021 TREANDA
NDA #022249		 SUPPL-25 BENDAMUSTINE HYDROCHLORIDE CEPHALON Labeling Approval
06/10/2021 LEVETIRACETAM
ANDA #091557		 SUPPL-9 LEVETIRACETAM ACTAVIS ELIZABETH Labeling Approval
06/10/2021 LEVETIRACETAM
ANDA #091557		 SUPPL-10 LEVETIRACETAM ACTAVIS ELIZABETH Labeling Approval
06/10/2021 LEVETIRACETAM
ANDA #091557		 SUPPL-11 LEVETIRACETAM ACTAVIS ELIZABETH Labeling Approval
06/10/2021 EPCLUSA
NDA #208341		 SUPPL-17 SOFOSBUVIR; VELPATASVIR GILEAD SCIENCES INC Efficacy Approval
06/10/2021 MAVYRET
NDA #209394		 SUPPL-13 GLECAPREVIR; PIBRENTASVIR ABBVIE INC Efficacy Approval
06/10/2021 TOFACITINIB
ANDA #209633		 ORIG-1 TOFACITINIB BRECKENRIDGE PHARMS Tentative Approval
06/10/2021 VENLAFAXINE HYDROCHLORIDE
ANDA #214127		 ORIG-1 VENLAFAXINE HYDROCHLORIDE ALKEM LABS LTD Approval
06/10/2021 EPCLUSA
NDA #214187		 ORIG-1 SOFOSBUVIR;VELPATASVIR GILEAD SCIENCES INC Type 3 - New Dosage Form Approval
06/10/2021 SODIUM PHENYLACETATE; SODIUM BENZOATE
NDA #215025		 ORIG-1 SODIUM PHENYLACETATE;SODIUM BENZOATE MAIA PHARMS INC Type 5 - New Formulation or New Manufacturer Approval
06/10/2021 MAVYRET
NDA #215110		 ORIG-1 GLECAPREVIR; PIBRENTASVIR ABBVIE INC Type 3 - New Dosage Form Approval
06/10/2021 RITUXAN HYCELA
BLA #761064		 SUPPL-13 RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) GENENTECH INC Approval
06/11/2021 HICON
NDA #021305		 SUPPL-47 SODIUM IODIDE I-131 JUBILANT Labeling Approval
06/11/2021 SODIUM IODIDE I 131
NDA #021305		 SUPPL-47 SODIUM IODIDE I-131 JUBILANT Labeling Approval
06/11/2021 VANCOLED
ANDA #062682		 SUPPL-18 VANCOMYCIN HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
06/11/2021 VANCOLED
ANDA #062682		 SUPPL-19 VANCOMYCIN HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
06/11/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #062879		 SUPPL-17 VANCOMYCIN HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
06/11/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #062879		 SUPPL-18 VANCOMYCIN HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
06/11/2021 LEVETIRACETAM
ANDA #091668		 SUPPL-1 LEVETIRACETAM SANDOZ Labeling Approval
06/11/2021 JARDIANCE
NDA #204629		 SUPPL-28 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 JARDIANCE
NDA #204629		 SUPPL-29 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 GLYXAMBI
NDA #206073		 SUPPL-27 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 GLYXAMBI
NDA #206073		 SUPPL-30 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 SYNJARDY
NDA #206111		 SUPPL-25 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 SYNJARDY
NDA #206111		 SUPPL-26 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 SYNJARDY XR
NDA #208658		 SUPPL-13 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 SYNJARDY XR
NDA #208658		 SUPPL-15 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 CARFILZOMIB
ANDA #209330		 ORIG-1 CARFILZOMIB BRECKENRIDGE Approval
06/11/2021 TEMAZEPAM
ANDA #211542		 SUPPL-1 TEMAZEPAM ALEMBIC PHARMS LTD Labeling Approval
06/11/2021 TEMAZEPAM
ANDA #211542		 SUPPL-8 TEMAZEPAM ALEMBIC PHARMS LTD Labeling Approval
06/11/2021 FULVESTRANT
ANDA #211730		 ORIG-1 FULVESTRANT APOTEX Approval
06/11/2021 TRIJARDY XR
NDA #212614		 SUPPL-8 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 TRIJARDY XR
NDA #212614		 SUPPL-10 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/11/2021 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #212797		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE XIAMEN LP PHARM CO Approval
06/11/2021 LEVETIRACETAM
ANDA #215069		 ORIG-1 LEVETIRACETAM SCIEGEN PHARMS INC Approval
06/11/2021 LEVETIRACETAM
ANDA #215069		 ORIG-2 LEVETIRACETAM SCIEGEN PHARMS INC Tentative Approval
06/14/2021 VALTREX
NDA #020487		 SUPPL-22 VALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
06/14/2021 SOLOSEC
NDA #209363		 SUPPL-15 SECNIDAZOLE LUPIN Labeling Approval
06/14/2021 SOAANZ
NDA #213218		 ORIG-1 TORSEMIDE SARFEZ PHARMACEUTICALS INC Type 5 - New Formulation or New Manufacturer Approval
06/14/2021 REZIPRES
NDA #213536		 ORIG-1 EPHEDRINE HYDROCHLORIDE SINTETICA, SA Type 5 - New Formulation or New Manufacturer Approval
06/14/2021 DUPIXENT
BLA #761055		 SUPPL-16 DUPILUMAB REGENERON PHARMACEUTICALS Approval

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English