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Drugs@FDA: FDA-Approved Drugs

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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 September 20, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2021 NICARDIPINE HYDROCHLORIDE
NDA #022276		 SUPPL-18 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
06/01/2021 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA #022276		 SUPPL-18 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
06/01/2021 ALBUTEROL SULFATE
ANDA #207085		 ORIG-1 ALBUTEROL SULFATE SANDOZ 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 LLC 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 LLC Labeling Approval
06/02/2021 AKYNZEO
NDA #205718		 SUPPL-9 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling 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 ELITE 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
BLA #761163		 SUPPL-1 TAFASITAMAB-CXIX MORPHOSYS US INC Approval
06/03/2021 BETAPACE
NDA #019865		 SUPPL-22 SOTALOL HYDROCHLORIDE LEGACY PHARMA 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 HIKMA 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 RISING 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 REYOUNG Labeling Approval
06/03/2021 FENOFIBRATE
ANDA #209660		 SUPPL-3 FENOFIBRATE CHARTWELL RX 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 RISING PHARMA 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 Labeling Approval
06/03/2021 FENOFIBRATE (MICRONIZED)
ANDA #213842		 SUPPL-1 FENOFIBRATE ALEMBIC 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 Labeling Approval
06/04/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091370		 SUPPL-26 HYDROCHLOROTHIAZIDE; IRBESARTAN ALEMBIC 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 CHARTWELL RX 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 EMERGENT BIODEFENSE Type 2 - New Active Ingredient Approval
06/04/2021 TEMBEXA
NDA #214461		 ORIG-1 BRINCIDOFOVIR EMERGENT BIODEFENSE 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 20,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-159 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
06/07/2021 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-159 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
06/07/2021 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
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 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #040716		 SUPPL-10 METHOTREXATE SODIUM ACCORD HLTHCARE Labeling Approval
06/07/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #040767		 SUPPL-8 METHOTREXATE SODIUM ACCORD HLTHCARE Labeling Approval
06/07/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #040768		 SUPPL-10 METHOTREXATE SODIUM ACCORD HLTHCARE 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 RISING PHARMA 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 DEXMEDETOMIDINE HYDROCHLORIDE
NDA #206628		 SUPPL-17 DEXMEDETOMIDINE HYDROCHLORIDE HQ SPCLT PHARMA Manufacturing (CMC) 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 IN SODIUM CHLORIDE
NDA #212035		 ORIG-1 ARGATROBAN ACCORD HLTHCARE 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 ENDO OPERATIONS REMS Approval
06/08/2021 PERAMPANEL
ANDA #209877		 ORIG-1 PERAMPANEL ACCORD HLTHCARE Tentative 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 AMRYT 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 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 AND SODIUM BENZOATE
NDA #215025		 ORIG-1 SODIUM BENZOATE; SODIUM PHENYLACETATE MAIA PHARMS INC Type 5 - New Formulation or New Manufacturer Approval
06/10/2021 MAVYRET
NDA #215110		 ORIG-1 GLECAPREVIR; PIBRENTASVIR ABBVIE 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 HIKMA Labeling Approval
06/11/2021 VANCOLED
ANDA #062682		 SUPPL-19 VANCOMYCIN HYDROCHLORIDE HIKMA Labeling Approval
06/11/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #062879		 SUPPL-17 VANCOMYCIN HYDROCHLORIDE HIKMA Labeling Approval
06/11/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #062879		 SUPPL-18 VANCOMYCIN HYDROCHLORIDE HIKMA 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 CARFILZOMIB
ANDA #209330		 ORIG-2 CARFILZOMIB BRECKENRIDGE Tentative Approval
06/11/2021 TEMAZEPAM
ANDA #211542		 SUPPL-1 TEMAZEPAM ALEMBIC Labeling Approval
06/11/2021 TEMAZEPAM
ANDA #211542		 SUPPL-8 TEMAZEPAM ALEMBIC 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
06/14/2021 VALTREX
NDA #020487		 SUPPL-22 VALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
06/14/2021 TREXALL
ANDA #040385		 SUPPL-21 METHOTREXATE SODIUM BARR Labeling Approval
06/14/2021 DIAZEPAM
ANDA #070313		 SUPPL-24 DIAZEPAM HIKMA Labeling Approval
06/14/2021 METHYLIN ER
ANDA #075629		 SUPPL-18 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/14/2021 METHYLIN ER
ANDA #075629		 SUPPL-20 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/14/2021 LIDOCAINE HYDROCHLORIDE
ANDA #083158		 SUPPL-122 LIDOCAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
06/14/2021 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%
ANDA #083158		 SUPPL-122 LIDOCAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
06/14/2021 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
ANDA #083158		 SUPPL-122 LIDOCAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
06/14/2021 DRONABINOL
ANDA #201463		 SUPPL-6 DRONABINOL LANNETT CO INC Manufacturing (CMC) Approval
06/14/2021 SODIUM BICARBONATE
ANDA #202494		 SUPPL-9 SODIUM BICARBONATE HOSPIRA Manufacturing (CMC) Approval
06/14/2021 SODIUM BICARBONATE
ANDA #202495		 SUPPL-9 SODIUM BICARBONATE HOSPIRA Manufacturing (CMC) Approval
06/14/2021 SODIUM BICARBONATE
ANDA #202679		 SUPPL-10 SODIUM BICARBONATE HOSPIRA Manufacturing (CMC) Approval
06/14/2021 SOLOSEC
NDA #209363		 SUPPL-15 SECNIDAZOLE LUPIN Labeling Approval
06/14/2021 AMINOCAPROIC ACID
ANDA #212110		 ORIG-1 AMINOCAPROIC ACID EDENBRIDGE PHARMS Approval
06/14/2021 TESTOSTERONE
ANDA #212882		 ORIG-1 TESTOSTERONE ALEMBIC Approval
06/14/2021 SOAANZ
NDA #213218		 ORIG-1 TORSEMIDE SARFE PHARMS Type 5 - New Formulation or New Manufacturer Approval
06/14/2021 REZIPRES
NDA #213536		 ORIG-1 EPHEDRINE HYDROCHLORIDE DR REDDYS LABS SA Type 5 - New Formulation or New Manufacturer Approval
06/14/2021 ETRAVIRINE
ANDA #214196		 ORIG-1 ETRAVIRINE AMNEAL Approval
06/14/2021 EPHEDRINE SULFATE
ANDA #214579		 ORIG-1 EPHEDRINE SULFATE EUGIA PHARMA Approval
06/14/2021 CLOBETASOL PROPIONATE
ANDA #214895		 ORIG-1 CLOBETASOL PROPIONATE AMNEAL Approval
06/14/2021 DUPIXENT
BLA #761055		 SUPPL-16 DUPILUMAB REGENERON PHARMACEUTICALS Approval
06/15/2021 LYSODREN
NDA #016885		 SUPPL-29 MITOTANE HRA PHARMA Labeling Approval
06/15/2021 PROSCAR
NDA #020180		 SUPPL-47 FINASTERIDE ORGANON Labeling Approval
06/15/2021 PROPECIA
NDA #020788		 SUPPL-28 FINASTERIDE ORGANON Labeling Approval
06/15/2021 CYRAMZA
BLA #125477		 SUPPL-39 RAMUCIRUMAB ELI LILLY AND CO Approval
06/15/2021 SAPROPTERIN DIHYDROCHLORIDE
ANDA #207685		 ORIG-1 SAPROPTERIN DIHYDROCHLORIDE DR REDDYS Approval
06/15/2021 SILDENAFIL CITRATE
ANDA #209302		 SUPPL-3 SILDENAFIL CITRATE UMEDICA Manufacturing (CMC) Approval
06/15/2021 SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE
ANDA #212903		 ORIG-1 SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE ANNORA PHARMA Tentative Approval
06/15/2021 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #214930		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ALKEM LABS LTD Approval
06/16/2021 ZELAPAR
NDA #021479		 SUPPL-10 SELEGILINE HYDROCHLORIDE BAUSCH Labeling Approval
06/16/2021 ALPRAZOLAM
ANDA #074312		 SUPPL-16 ALPRAZOLAM HIKMA Manufacturing (CMC) Approval
06/16/2021 EFAVIRENZ
ANDA #078509		 ORIG-1 EFAVIRENZ STRIDES PHARMA Approval
06/16/2021 IBANDRONATE SODIUM
ANDA #204329		 ORIG-1 IBANDRONATE SODIUM NANG KUANG PHARM CO Approval
06/16/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #208740		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE APOTEX Approval
06/16/2021 IBUPROFEN
ANDA #209179		 SUPPL-1 IBUPROFEN AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
06/16/2021 TALZENNA
NDA #211651		 SUPPL-1 TALAZOPARIB TOSYLATE PFIZER Labeling Approval
06/16/2021 MICAFUNGIN
NDA #212156		 ORIG-1 MICAFUNGIN SODIUM ENDO OPERATIONS Type 5 - New Formulation or New Manufacturer Approval
06/16/2021 AYVAKIT
NDA #212608		 SUPPL-6 AVAPRITINIB BLUEPRINT MEDICINES Efficacy Approval
06/16/2021 AYVAKIT
NDA #212608		 SUPPL-7 AVAPRITINIB BLUEPRINT MEDICINES Efficacy Approval
06/16/2021 SEVELAMER HYDROCHLORIDE
ANDA #213145		 ORIG-1 SEVELAMER HYDROCHLORIDE LUPIN LTD Approval
06/17/2021 ZOLADEX
NDA #019726		 SUPPL-66 GOSERELIN ACETATE TERSERA Labeling Approval
06/17/2021 ZOLADEX
NDA #020578		 SUPPL-44 GOSERELIN ACETATE TERSERA Labeling Approval
06/17/2021 BYETTA
NDA #021773		 SUPPL-44 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
06/17/2021 TOVIAZ
NDA #022030		 SUPPL-19 FESOTERODINE FUMARATE PFIZER Efficacy Approval
06/17/2021 RIFADIN
NDA #050420		 SUPPL-85 RIFAMPIN SANOFI AVENTIS US Labeling Approval
06/17/2021 RIFADIN
NDA #050627		 SUPPL-28 RIFAMPIN SANOFI AVENTIS US Labeling Approval
06/17/2021 RIFATER
NDA #050705		 SUPPL-19 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
06/17/2021 OLANZAPINE
ANDA #090881		 SUPPL-8 OLANZAPINE SUN PHARM INDS Labeling Approval
06/17/2021 OLANZAPINE
ANDA #091038		 SUPPL-7 OLANZAPINE SUN PHARM INDS Labeling Approval
06/17/2021 INFLECTRA
BLA #125544		 SUPPL-18 INFLIXIMAB-DYYB CELLTRION INC Approval
06/17/2021 NOXAFIL
NDA #205053		 SUPPL-11 POSACONAZOLE MERCK SHARP DOHME Efficacy Approval
06/17/2021 NOXAFIL
NDA #205596		 SUPPL-13 POSACONAZOLE MERCK SHARP DOHME Efficacy Approval
06/17/2021 CALCIUM GLUCONATE
NDA #208418		 SUPPL-7 CALCIUM GLUCONATE FRESENIUS KABI USA Labeling Approval
06/17/2021 CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #208418		 SUPPL-7 CALCIUM GLUCONATE FRESENIUS KABI USA Labeling Approval
06/17/2021 PERAMPANEL
ANDA #209538		 ORIG-1 PERAMPANEL TARO PHARM INDS LTD Tentative Approval
06/17/2021 SUBLOCADE
NDA #209819		 SUPPL-18 BUPRENORPHINE INDIVIOR Labeling Approval
06/17/2021 DIMETHYL FUMARATE
ANDA #210531		 SUPPL-1 DIMETHYL FUMARATE MYLAN Manufacturing (CMC) Approval
06/17/2021 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #211438		 ORIG-1 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE HETERO LABS LTD V Approval
06/17/2021 FENTANYL CITRATE
ANDA #212086		 SUPPL-1 FENTANYL CITRATE FRESENIUS KABI USA Manufacturing (CMC) Approval
06/17/2021 ASTEPRO ALLERGY
NDA #213872		 ORIG-1 AZELASTINE HYDROCHLORIDE BAYER HLTHCARE Type 8 - Partial Rx to OTC Switch Approval
06/17/2021 CHILDREN'S ASTEPRO ALLERGY
NDA #213872		 ORIG-1 AZELASTINE HYDROCHLORIDE BAYER HLTHCARE Type 8 - Partial Rx to OTC Switch Approval
06/17/2021 LEVORPHANOL TARTRATE
ANDA #213906		 ORIG-1 LEVORPHANOL TARTRATE SUN PHARM INDS INC Approval
06/17/2021 QINLOCK
NDA #213973		 SUPPL-1 RIPRETINIB DECIPHERA PHARMS Labeling Approval
06/21/2021 PRADAXA
NDA #022512		 SUPPL-41 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Efficacy Approval
06/21/2021 TOBRAMYCIN
ANDA #064052		 SUPPL-38 TOBRAMYCIN BAUSCH AND LOMB Labeling Approval
06/21/2021 TOBRAMYCIN
ANDA #064052		 SUPPL-39 TOBRAMYCIN BAUSCH AND LOMB Labeling Approval
06/21/2021 AMPICILLIN AND SULBACTAM
ANDA #065240		 SUPPL-23 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
06/21/2021 AMPICILLIN AND SULBACTAM
ANDA #065241		 SUPPL-23 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
06/21/2021 DOPAMINE HYDROCHLORIDE
ANDA #070799		 SUPPL-17 DOPAMINE HYDROCHLORIDE AM REGENT Labeling Approval
06/21/2021 DOPAMINE HYDROCHLORIDE
ANDA #070820		 SUPPL-17 DOPAMINE HYDROCHLORIDE AM REGENT Labeling Approval
06/21/2021 DOPAMINE HYDROCHLORIDE
ANDA #070826		 SUPPL-16 DOPAMINE HYDROCHLORIDE AM REGENT Labeling Approval
06/21/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204772		 SUPPL-3 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Labeling Approval
06/21/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207488		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE ABHAI LLC Labeling Approval
06/21/2021 DAPTOMYCIN
NDA #210282		 ORIG-1 DAPTOMYCIN HOSPIRA Type 5 - New Formulation or New Manufacturer Approval
06/21/2021 EFINACONAZOLE
ANDA #211969		 ORIG-1 EFINACONAZOLE UMEDICA Approval
06/21/2021 OXCARBAZEPINE
ANDA #212428		 ORIG-1 OXCARBAZEPINE CHARTWELL RX Approval
06/21/2021 PRADAXA
NDA #214358		 ORIG-1 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Type 3 - New Dosage Form Approval
06/22/2021 AZOPT
NDA #020816		 SUPPL-23 BRINZOLAMIDE SANDOZ Labeling Approval
06/22/2021 CARDURA XL
NDA #021269		 SUPPL-21 DOXAZOSIN MESYLATE VIATRIS Labeling Approval
06/22/2021 CHLOROPROCAINE HYDROCHLORIDE
ANDA #087446		 SUPPL-19 CHLOROPROCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/22/2021 METRONIDAZOLE
ANDA #090222		 SUPPL-2 METRONIDAZOLE ALEMBIC Labeling Approval
06/22/2021 LETROZOLE
ANDA #090289		 SUPPL-9 LETROZOLE TEVA PHARMS Manufacturing (CMC) Approval
06/22/2021 VORICONAZOLE
ANDA #090862		 SUPPL-8 VORICONAZOLE SANDOZ INC Labeling Approval
06/22/2021 VORICONAZOLE
ANDA #090862		 SUPPL-9 VORICONAZOLE SANDOZ INC Labeling Approval
06/22/2021 VORICONAZOLE
ANDA #090862		 SUPPL-10 VORICONAZOLE SANDOZ INC Labeling Approval
06/22/2021 VORICONAZOLE
ANDA #090862		 SUPPL-11 VORICONAZOLE SANDOZ INC Labeling Approval
06/22/2021 VORICONAZOLE
ANDA #090862		 SUPPL-12 VORICONAZOLE SANDOZ INC Labeling Approval
06/22/2021 VORICONAZOLE
ANDA #090862		 SUPPL-13 VORICONAZOLE SANDOZ INC Labeling Approval
06/22/2021 FORMOTEROL FUMARATE
ANDA #091141		 ORIG-1 FORMOTEROL FUMARATE TEVA PHARMS USA INC Approval
06/22/2021 HEMANGEOL
NDA #205410		 SUPPL-6 PROPRANOLOL HYDROCHLORIDE PIERRE FABRE Labeling Approval
06/22/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #205756		 SUPPL-2 METHYLPHENIDATE HYDROCHLORIDE RISING PHARMA Labeling Approval
06/22/2021 ARFORMOTEROL TARTRATE
ANDA #207306		 ORIG-1 ARFORMOTEROL TARTRATE CIPLA Approval
06/22/2021 NETSPOT
NDA #208547		 SUPPL-20 GALLIUM DOTATATE GA-68 AAA USA INC Labeling Approval
06/22/2021 NETSPOT
NDA #208547		 SUPPL-22 GALLIUM DOTATATE GA-68 AAA USA INC Labeling Approval
06/22/2021 BIJUVA
NDA #210132		 SUPPL-1 ESTRADIOL; PROGESTERONE MAYNE PHARMA Labeling Approval
06/22/2021 BIJUVA
NDA #210132		 SUPPL-3 ESTRADIOL; PROGESTERONE MAYNE PHARMA Labeling Approval
06/22/2021 MEDROXYPROGESTERONE ACETATE
ANDA #210760		 SUPPL-7 MEDROXYPROGESTERONE ACETATE SUN PHARM Labeling Approval
06/22/2021 MEDROXYPROGESTERONE ACETATE
ANDA #210760		 SUPPL-8 MEDROXYPROGESTERONE ACETATE SUN PHARM Labeling Approval
06/22/2021 MEDROXYPROGESTERONE ACETATE
ANDA #210761		 SUPPL-8 MEDROXYPROGESTERONE ACETATE SUN PHARM Labeling Approval
06/22/2021 MEDROXYPROGESTERONE ACETATE
ANDA #210761		 SUPPL-9 MEDROXYPROGESTERONE ACETATE SUN PHARM Labeling Approval
06/22/2021 NINTEDANIB
ANDA #212555		 ORIG-1 NINTEDANIB ESYLATE GLENMARK PHARMS LTD Tentative Approval
06/22/2021 ARFORMOTEROL TARTRATE
ANDA #213132		 ORIG-1 ARFORMOTEROL TARTRATE GLENMARK PHARMS LTD Approval
06/22/2021 ARFORMOTEROL TARTRATE
ANDA #213762		 ORIG-1 ARFORMOTEROL TARTRATE SLATE RUN PHARMA Approval
06/23/2021 CARDURA
NDA #019668		 SUPPL-32 DOXAZOSIN MESYLATE VIATRIS Labeling Approval
06/23/2021 OLOPATADINE HYDROCHLORIDE
ANDA #204532		 SUPPL-4 OLOPATADINE HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
06/23/2021 OLOPATADINE HYDROCHLORIDE
ANDA #204723		 SUPPL-3 OLOPATADINE HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
06/23/2021 ACETAMINOPHEN
NDA #204767		 SUPPL-7 ACETAMINOPHEN FRESENIUS KABI USA Labeling Approval
06/23/2021 EPINEPHRINE
NDA #205029		 SUPPL-8 EPINEPHRINE BPI LABS Labeling Approval
06/23/2021 DIAZEPAM
ANDA #210363		 SUPPL-5 DIAZEPAM BELOTECA Labeling Approval
06/23/2021 DIAZEPAM
ANDA #210363		 SUPPL-6 DIAZEPAM BELOTECA Labeling Approval
06/23/2021 XYWAV
NDA #212690		 SUPPL-5 CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE JAZZ Labeling Approval
06/23/2021 VERKAZIA
NDA #214965		 ORIG-1 CYCLOSPORINE HARROW EYE Type 5 - New Formulation or New Manufacturer Approval
06/24/2021 ELLA
NDA #022474		 SUPPL-11 ULIPRISTAL ACETATE LAB HRA PHARMA Efficacy Approval
06/24/2021 TOBREX
ANDA #062535		 SUPPL-31 TOBRAMYCIN SANDOZ Labeling Approval
06/24/2021 TOBREX
ANDA #062535		 SUPPL-33 TOBRAMYCIN SANDOZ Labeling Approval
06/24/2021 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076345		 SUPPL-34 GLYBURIDE; METFORMIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
06/24/2021 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076345		 SUPPL-36 GLYBURIDE; METFORMIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
06/24/2021 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076821		 SUPPL-4 GLYBURIDE; METFORMIN HYDROCHLORIDE TEVA Labeling Approval
06/24/2021 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076821		 SUPPL-5 GLYBURIDE; METFORMIN HYDROCHLORIDE TEVA Labeling Approval
06/24/2021 TRANEXAMIC ACID
ANDA #091596		 SUPPL-5 TRANEXAMIC ACID FRESENIUS KABI USA Labeling Approval
06/24/2021 TRANEXAMIC ACID
ANDA #206713		 SUPPL-4 TRANEXAMIC ACID MICRO LABS Labeling Approval
06/24/2021 AUSTEDO
NDA #208082		 SUPPL-9 DEUTETRABENAZINE TEVA BRANDED PHARM Efficacy Approval
06/24/2021 TRANEXAMIC ACID
ANDA #208840		 SUPPL-2 TRANEXAMIC ACID AMNEAL PHARMS CO Labeling Approval
06/24/2021 TRANEXAMIC ACID
ANDA #208840		 SUPPL-4 TRANEXAMIC ACID AMNEAL PHARMS CO Labeling Approval
06/24/2021 ZURAGARD
NDA #210872		 SUPPL-1 ISOPROPYL ALCOHOL ZUREX PHARMA Efficacy Approval
06/24/2021 HEMADY
NDA #211379		 SUPPL-3 DEXAMETHASONE DEXCEL Labeling Approval
06/25/2021 ROWASA
NDA #019618		 SUPPL-27 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
06/25/2021 SFROWASA
NDA #019618		 SUPPL-27 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
06/25/2021 DIPENTUM
NDA #019715		 SUPPL-29 OLSALAZINE SODIUM MYLAN SPCLT VIATRIS Labeling Approval
06/25/2021 CONCERTA
NDA #021121		 SUPPL-44 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
06/25/2021 METADATE CD
NDA #021259		 SUPPL-32 METHYLPHENIDATE HYDROCHLORIDE AYTU BIOPHARMA Labeling Approval
06/25/2021 METHYLIN
NDA #021419		 SUPPL-20 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/25/2021 METHYLIN
NDA #021475		 SUPPL-11 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/25/2021 DAYTRANA
NDA #021514		 SUPPL-32 METHYLPHENIDATE NOVEN PHARMS INC Labeling Approval
06/25/2021 BRIDION
NDA #022225		 SUPPL-8 SUGAMMADEX SODIUM MSD SUB MERCK Efficacy Approval
06/25/2021 METADATE ER
ANDA #040306		 SUPPL-20 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
06/25/2021 SUFENTANIL CITRATE
ANDA #074534		 SUPPL-14 SUFENTANIL CITRATE HOSPIRA Labeling Approval
06/25/2021 SUFENTANIL CITRATE
ANDA #074534		 SUPPL-15 SUFENTANIL CITRATE HOSPIRA Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #075450		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
06/25/2021 METHYLIN ER
ANDA #075629		 SUPPL-23 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/25/2021 METADATE ER
ANDA #089601		 SUPPL-36 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
06/25/2021 METFORMIN HYDROCHLORIDE
ANDA #090295		 SUPPL-2 METFORMIN HYDROCHLORIDE MARKSANS PHARMA Labeling Approval
06/25/2021 METFORMIN HYDROCHLORIDE
ANDA #090295		 SUPPL-3 METFORMIN HYDROCHLORIDE MARKSANS PHARMA Labeling Approval
06/25/2021 TEMOZOLOMIDE
ANDA #201742		 SUPPL-13 TEMOZOLOMIDE SUN PHARM Labeling Approval
06/25/2021 TEMOZOLOMIDE
ANDA #201742		 SUPPL-16 TEMOZOLOMIDE SUN PHARM Labeling Approval
06/25/2021 QUILLIVANT XR
NDA #202100		 SUPPL-18 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE Labeling Approval
06/25/2021 IBUPROFEN
ANDA #202413		 SUPPL-16 IBUPROFEN SHANDONG XINHUA Labeling Approval
06/25/2021 IBUPROFEN
ANDA #202413		 SUPPL-17 IBUPROFEN SHANDONG XINHUA Labeling Approval
06/25/2021 METFORMIN HYDROCHLORIDE
ANDA #203832		 SUPPL-3 METFORMIN HYDROCHLORIDE NOSTRUM LABS INC Labeling Approval
06/25/2021 METFORMIN HYDROCHLORIDE
ANDA #203832		 SUPPL-4 METFORMIN HYDROCHLORIDE NOSTRUM LABS INC Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204115		 SUPPL-5 METHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Labeling Approval
06/25/2021 DECITABINE
ANDA #204607		 SUPPL-5 DECITABINE PHARMASCIENCE INC Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204954		 SUPPL-3 METHYLPHENIDATE HYDROCHLORIDE NOSTRUM LABS INC Labeling Approval
06/25/2021 COTEMPLA XR-ODT
NDA #205489		 SUPPL-7 METHYLPHENIDATE NEOS THERAPS INC Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #205756		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE RISING PHARMA Labeling Approval
06/25/2021 APTENSIO XR
NDA #205831		 SUPPL-6 METHYLPHENIDATE HYDROCHLORIDE RHODES PHARMS Labeling Approval
06/25/2021 GEMCITABINE HYDROCHLORIDE
ANDA #206617		 ORIG-1 GEMCITABINE HYDROCHLORIDE HIKMA INTL PHARMS Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207488		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE ABHAI LLC Labeling Approval
06/25/2021 QUILLICHEW ER
NDA #207960		 SUPPL-12 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE PHARMS Labeling Approval
06/25/2021 JORNAY PM
NDA #209311		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE IRONSHORE PHARMS Labeling Approval
06/25/2021 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209468		 SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
06/25/2021 CAROSPIR
NDA #209478		 SUPPL-3 SPIRONOLACTONE CMP DEV LLC Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #210354		 SUPPL-3 METHYLPHENIDATE HYDROCHLORIDE ASCENT PHARMS INC Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #210992		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE GRANULES Labeling Approval
06/25/2021 GABAPENTIN
ANDA #211330		 SUPPL-1 GABAPENTIN PAI HOLDINGS PHARM Labeling Approval
06/25/2021 GABAPENTIN
ANDA #211330		 SUPPL-2 GABAPENTIN PAI HOLDINGS PHARM Labeling Approval
06/25/2021 NITROFURANTOIN
ANDA #211935		 ORIG-1 NITROFURANTOIN, MACROCRYSTALLINE ALEMBIC Approval
06/25/2021 ADHANSIA XR
NDA #212038		 SUPPL-5 METHYLPHENIDATE HYDROCHLORIDE PURDUE PHARMA LP Labeling Approval
06/25/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #212288		 SUPPL-1 METHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
06/25/2021 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
NDA #212303		 ORIG-1 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE LUPIN PHARMS Type 4 - New Combination Tentative Approval
06/25/2021 DOCETAXEL
ANDA #214575		 ORIG-1 DOCETAXEL EUGIA PHARMA Approval
06/26/2021 RITALIN
NDA #010187		 SUPPL-93 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/26/2021 FOCALIN
NDA #021278		 SUPPL-29 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/26/2021 RITALIN LA
NDA #021284		 SUPPL-43 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/26/2021 FOCALIN XR
NDA #021802		 SUPPL-39 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/28/2021 ASTEPRO
NDA #022203		 SUPPL-18 AZELASTINE HYDROCHLORIDE MYLAN SPECIALITY LP Labeling Approval
06/28/2021 AVEED
NDA #022219		 SUPPL-16 TESTOSTERONE UNDECANOATE ENDO OPERATIONS REMS Approval
06/28/2021 KEYTRUDA
BLA #125514		 SUPPL-108 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/28/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204772		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Labeling Approval
06/28/2021 METFORMIN HYDROCHLORIDE
ANDA #205096		 SUPPL-2 METFORMIN HYDROCHLORIDE CSPC OUYI Labeling Approval
06/28/2021 METFORMIN HYDROCHLORIDE
ANDA #205096		 SUPPL-6 METFORMIN HYDROCHLORIDE CSPC OUYI Labeling Approval
06/28/2021 NERLYNX
NDA #208051		 SUPPL-9 NERATINIB MALEATE PUMA BIOTECH Efficacy Approval
06/28/2021 SYMTUZA
NDA #210455		 SUPPL-17 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE JANSSEN PRODS Labeling Approval
06/28/2021 ADHANSIA XR
NDA #212038		 SUPPL-2 METHYLPHENIDATE HYDROCHLORIDE PURDUE PHARMA LP Efficacy Approval
06/28/2021 ERYTHROMYCIN
ANDA #213628		 ORIG-1 ERYTHROMYCIN CADILA PHARMS LTD Approval
06/28/2021 CLINDAMYCIN PHOSPHATE
ANDA #214526		 ORIG-1 CLINDAMYCIN PHOSPHATE TARO Approval
06/29/2021 SPRYCEL
NDA #021986		 SUPPL-25 DASATINIB BRISTOL MYERS SQUIBB Labeling Approval
06/29/2021 PALONOSETRON HYDROCHLORIDE
ANDA #202951		 ORIG-1 PALONOSETRON HYDROCHLORIDE AVET LIFESCIENCES Approval
06/29/2021 BUPRENORPHINE
ANDA #204937		 SUPPL-5 BUPRENORPHINE WATSON LABS TEVA Manufacturing (CMC) Approval
06/29/2021 SYMJEPI
NDA #207534		 SUPPL-12 EPINEPHRINE ADAMIS PHARMS CORP Labeling Approval
06/29/2021 EMFLAZA
NDA #208684		 SUPPL-5 DEFLAZACORT PTC THERAP Labeling Approval
06/29/2021 EMFLAZA
NDA #208685		 SUPPL-5 DEFLAZACORT PTC THERAP Labeling Approval
06/29/2021 ESLICARBAZEPINE ACETATE
ANDA #211238		 ORIG-1 ESLICARBAZEPINE ACETATE DR REDDYS Approval
06/29/2021 DAPTOMYCIN
ANDA #213623		 ORIG-1 DAPTOMYCIN MEITHEAL Approval
06/29/2021 DAPTOMYCIN
ANDA #213786		 ORIG-1 DAPTOMYCIN MEITHEAL Approval
06/30/2021 TOPAMAX
NDA #020505		 SUPPL-63 TOPIRAMATE JANSSEN PHARMS Labeling Approval
06/30/2021 TOPAMAX
NDA #020844		 SUPPL-54 TOPIRAMATE JANSSEN PHARMS Labeling Approval
06/30/2021 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-54 TOPIRAMATE JANSSEN PHARMS Labeling Approval
06/30/2021 RITUXAN
BLA #103705		 SUPPL-5464 RITUXIMAB GENENTECH Approval
06/30/2021 SOLOSEC
NDA #209363		 SUPPL-12 SECNIDAZOLE LUPIN Efficacy Approval
06/30/2021 MULTRYS
NDA #209376		 SUPPL-2 CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE AM REGENT Manufacturing (CMC) Approval
06/30/2021 TRALEMENT
NDA #209376		 SUPPL-2 CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE AM REGENT Manufacturing (CMC) Approval
06/30/2021 ICOSAPENT ETHYL
ANDA #209437		 ORIG-1 ICOSAPENT ETHYL APOTEX Approval
06/30/2021 APREMILAST
ANDA #211782		 ORIG-1 APREMILAST AMNEAL Approval
06/30/2021 VENLAFAXINE HYDROCHLORIDE
ANDA #214609		 ORIG-1 VENLAFAXINE HYDROCHLORIDE APPCO Approval
06/30/2021 RYLAZE
BLA #761179		 ORIG-1 ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN JAZZ PHARMS Approval
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