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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 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 18, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2021 ALEVE
NDA #020204		 SUPPL-81 NAPROXEN SODIUM BAYER Labeling Approval
04/01/2021 DICLOFENAC POTASSIUM
ANDA #075219		 SUPPL-14 DICLOFENAC POTASSIUM TEVA Labeling Approval
04/01/2021 OXYMORPHONE HYDROCHLORIDE
ANDA #091443		 SUPPL-7 OXYMORPHONE HYDROCHLORIDE TEVA Labeling Approval
04/01/2021 OXYMORPHONE HYDROCHLORIDE
ANDA #091443		 SUPPL-10 OXYMORPHONE HYDROCHLORIDE TEVA Labeling Approval
04/01/2021 IBUPROFEN
ANDA #091625		 SUPPL-11 IBUPROFEN GRANULES Labeling Approval
04/01/2021 PRALUENT
BLA #125559		 SUPPL-29 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
04/01/2021 PRALUENT
BLA #125559		 SUPPL-30 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
04/01/2021 DICLOFENAC SODIUM
ANDA #202393		 SUPPL-1 DICLOFENAC SODIUM TWI PHARMS Labeling Approval
04/01/2021 CASPOFUNGIN ACETATE
NDA #206110		 SUPPL-3 CASPOFUNGIN ACETATE FRESENIUS KABI USA Labeling Approval
04/01/2021 TOBRAMYCIN
ANDA #212848		 ORIG-1 TOBRAMYCIN ALKEM LABS LTD Approval
04/01/2021 BOSENTAN
ANDA #213154		 ORIG-1 BOSENTAN NATCO PHARMA LTD Tentative Approval
04/01/2021 DOXEPIN HYDROCHLORIDE
ANDA #214908		 ORIG-1 DOXEPIN HYDROCHLORIDE APPCO Approval
04/02/2021 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-38 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
04/02/2021 CLARITIN
NDA #021891		 SUPPL-38 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
04/02/2021 INDOMETHACIN
ANDA #070624		 SUPPL-35 INDOMETHACIN RISING Labeling Approval
04/02/2021 INDOMETHACIN
ANDA #070624		 SUPPL-38 INDOMETHACIN RISING Labeling Approval
04/02/2021 LOPERAMIDE HYDROCHLORIDE
ANDA #076497		 SUPPL-7 LOPERAMIDE HYDROCHLORIDE LNK Labeling Approval
04/02/2021 RAMIPRIL
ANDA #077626		 SUPPL-21 RAMIPRIL LUPIN Labeling Approval
04/02/2021 RAMIPRIL
ANDA #078832		 SUPPL-16 RAMIPRIL ZYDUS PHARMS USA Labeling Approval
04/02/2021 LETROZOLE
ANDA #090934		 SUPPL-11 LETROZOLE ACCORD HLTHCARE Labeling Approval
04/02/2021 LETROZOLE
ANDA #090934		 SUPPL-14 LETROZOLE ACCORD HLTHCARE Labeling Approval
04/02/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090958		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE CIPLA Approval
04/02/2021 RAMIPRIL
ANDA #091604		 SUPPL-8 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
04/02/2021 OLOPATADINE HYDROCHLORIDE
ANDA #203152		 SUPPL-6 OLOPATADINE HYDROCHLORIDE USV Labeling Approval
04/02/2021 DICLOFENAC SODIUM
ANDA #203818		 SUPPL-1 DICLOFENAC SODIUM TARO Labeling Approval
04/02/2021 MEMANTINE HYDROCHLORIDE
ANDA #211100		 ORIG-1 MEMANTINE HYDROCHLORIDE YICHANG HUMANWELL Approval
04/02/2021 QELBREE
NDA #211964		 ORIG-1 VILOXAZINE HYDROCHLORIDE SUPERNUS PHARMS Type 1 - New Molecular Entity Approval
04/02/2021 DEOXYCHOLIC ACID
ANDA #212296		 ORIG-1 DEOXYCHOLIC ACID WILSHIRE PHARMS INC Approval
04/02/2021 FLUOCINOLONE ACETONIDE
ANDA #212760		 ORIG-1 FLUOCINOLONE ACETONIDE QUAGEN Approval
04/02/2021 FLUOCINOLONE ACETONIDE
ANDA #212761		 ORIG-1 FLUOCINOLONE ACETONIDE QUAGEN Approval
04/02/2021 FLUOCINOLONE ACETONIDE
ANDA #212762		 ORIG-1 FLUOCINOLONE ACETONIDE QUAGEN Approval
04/05/2021 REGONOL
NDA #017398		 SUPPL-25 PYRIDOSTIGMINE BROMIDE SANDOZ Labeling Approval
04/05/2021 TOLMETIN SODIUM
ANDA #073462		 SUPPL-5 TOLMETIN SODIUM CHARTWELL RX Labeling Approval
04/05/2021 TOLMETIN SODIUM
ANDA #073588		 SUPPL-3 TOLMETIN SODIUM CHARTWELL RX Labeling Approval
04/05/2021 TOLMETIN SODIUM
ANDA #074002		 SUPPL-2 TOLMETIN SODIUM CHARTWELL RX Labeling Approval
04/05/2021 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090392		 SUPPL-4 LEVOCETIRIZINE DIHYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
04/05/2021 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090392		 SUPPL-5 LEVOCETIRIZINE DIHYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
04/05/2021 LEVETIRACETAM
ANDA #091291		 SUPPL-5 LEVETIRACETAM CHARTWELL RX Labeling Approval
04/05/2021 LEVETIRACETAM
ANDA #091291		 SUPPL-6 LEVETIRACETAM CHARTWELL RX Labeling Approval
04/05/2021 LEVETIRACETAM
ANDA #091291		 SUPPL-7 LEVETIRACETAM CHARTWELL RX Labeling Approval
04/05/2021 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201087		 SUPPL-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN STRIDES PHARMA Labeling Approval
04/05/2021 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201087		 SUPPL-6 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN STRIDES PHARMA Labeling Approval
04/05/2021 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201087		 SUPPL-7 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN STRIDES PHARMA Labeling Approval
04/05/2021 LEVETIRACETAM
ANDA #207175		 SUPPL-1 LEVETIRACETAM HISUN PHARM HANGZHOU Labeling Approval
04/05/2021 LEVETIRACETAM
ANDA #207175		 SUPPL-2 LEVETIRACETAM HISUN PHARM HANGZHOU Labeling Approval
04/05/2021 LEVETIRACETAM
ANDA #207175		 SUPPL-3 LEVETIRACETAM HISUN PHARM HANGZHOU Labeling Approval
04/05/2021 ABIRATERONE ACETATE
ANDA #209227		 SUPPL-2 ABIRATERONE ACETATE GLENMARK SPECLT Labeling Approval
04/05/2021 NALOXONE HYDROCHLORIDE
ANDA #209522		 SUPPL-2 NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
04/05/2021 NALOXONE HYDROCHLORIDE
ANDA #209522		 SUPPL-4 NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
04/05/2021 ABIRATERONE ACETATE
ANDA #210686		 SUPPL-2 ABIRATERONE ACETATE MSN Labeling Approval
04/05/2021 ABIRATERONE ACETATE
ANDA #212462		 SUPPL-1 ABIRATERONE ACETATE QILU Labeling Approval
04/05/2021 NEOSTIGMINE METHYLSULFATE
ANDA #212804		 ORIG-1 NEOSTIGMINE METHYLSULFATE MEITHEAL Approval
04/06/2021 ERBITUX
BLA #125084		 SUPPL-277 CETUXIMAB IMCLONE Approval
04/06/2021 ERBITUX
BLA #125084		 SUPPL-280 CETUXIMAB IMCLONE Approval
04/06/2021 TRANEXAMIC ACID
ANDA #205035		 SUPPL-4 TRANEXAMIC ACID EUGIA PHARMA Labeling Approval
04/06/2021 BUDESONIDE
ANDA #205710		 SUPPL-9 BUDESONIDE CIPLA Labeling Approval
04/06/2021 FULVESTRANT
NDA #210063		 SUPPL-2 FULVESTRANT TEVA PHARMS USA INC Labeling Approval
04/06/2021 MACITENTAN
ANDA #211224		 ORIG-1 MACITENTAN ZYDUS LIFESCIENCES Approval
04/07/2021 EXFORGE
NDA #021990		 SUPPL-41 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
04/07/2021 KETAMINE HYDROCHLORIDE
ANDA #074524		 SUPPL-18 KETAMINE HYDROCHLORIDE HIKMA Labeling Approval
04/07/2021 RIZATRIPTAN BENZOATE
ANDA #078173		 SUPPL-7 RIZATRIPTAN BENZOATE NORVIUM BIOSCIENCE Labeling Approval
04/07/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #091554		 SUPPL-14 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
04/07/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #091554		 SUPPL-15 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
04/07/2021 VILAZODONE HYDROCHLORIDE
ANDA #208200		 ORIG-1 VILAZODONE HYDROCHLORIDE INVAGEN PHARMS Approval
04/07/2021 TERIFLUNOMIDE
ANDA #209638		 SUPPL-4 TERIFLUNOMIDE AUROBINDO PHARMA Labeling Approval
04/07/2021 TERIFLUNOMIDE
ANDA #209663		 SUPPL-3 TERIFLUNOMIDE GLENMARK SPECLT Labeling Approval
04/07/2021 EFINACONAZOLE
ANDA #212027		 ORIG-1 EFINACONAZOLE ALEOR PHARMACEUTICALS LIMITED Tentative Approval
04/07/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #212332		 SUPPL-3 VANCOMYCIN HYDROCHLORIDE SLATE RUN PHARMA Labeling Approval
04/07/2021 SELEXIPAG
ANDA #214367		 ORIG-1 SELEXIPAG MSN LABORATORIES PRIVATE LTD Tentative Approval
04/07/2021 TRODELVY
BLA #761115		 SUPPL-5 SACITUZUMAB GOVITECAN-HZIY IMMUNOMEDICS INC Approval
04/07/2021 TRODELVY
BLA #761115		 SUPPL-13 SACITUZUMAB GOVITECAN-HZIY IMMUNOMEDICS INC Approval
04/08/2021 TIROFIBAN HYDROCHLORIDE
ANDA #206888		 ORIG-1 TIROFIBAN HYDROCHLORIDE GLAND PHARMA LTD Approval
04/08/2021 ZTLIDO
NDA #207962		 SUPPL-5 LIDOCAINE SCILEX PHARMS Efficacy Approval
04/08/2021 PANTOPRAZOLE SODIUM
ANDA #208580		 SUPPL-1 PANTOPRAZOLE SODIUM NORVIUM BIOSCIENCE Labeling Approval
04/08/2021 PANTOPRAZOLE SODIUM
ANDA #208580		 SUPPL-2 PANTOPRAZOLE SODIUM NORVIUM BIOSCIENCE Labeling Approval
04/08/2021 PANTOPRAZOLE SODIUM
ANDA #208580		 SUPPL-3 PANTOPRAZOLE SODIUM NORVIUM BIOSCIENCE Labeling Approval
04/08/2021 NICARDIPINE HYDROCHLORIDE
ANDA #211121		 ORIG-1 NICARDIPINE HYDROCHLORIDE EUGIA PHARMA Approval
04/08/2021 BYFAVO
NDA #212295		 SUPPL-2 REMIMAZOLAM BESYLATE ACACIA Labeling Approval
04/08/2021 AMINOCAPROIC ACID
ANDA #213825		 ORIG-1 AMINOCAPROIC ACID BELCHER Approval
04/08/2021 PIMAVANSERIN
ANDA #214750		 ORIG-1 PIMAVANSERIN TEVA PHARMS USA Tentative Approval
04/09/2021 DEFINITY
NDA #021064		 SUPPL-25 PERFLUTREN LANTHEUS MEDCL Labeling Approval
04/09/2021 DEFINITY
NDA #021064		 SUPPL-29 PERFLUTREN LANTHEUS MEDCL Labeling Approval
04/09/2021 DEFINITY RT
NDA #021064		 SUPPL-25 PERFLUTREN LANTHEUS MEDCL Labeling Approval
04/09/2021 DEFINITY RT
NDA #021064		 SUPPL-29 PERFLUTREN LANTHEUS MEDCL Labeling Approval
04/09/2021 FLUCONAZOLE
ANDA #074681		 SUPPL-9 FLUCONAZOLE TEVA Labeling Approval
04/09/2021 FLUCONAZOLE
ANDA #074681		 SUPPL-10 FLUCONAZOLE TEVA Labeling Approval
04/09/2021 FLUCONAZOLE
ANDA #074681		 SUPPL-11 FLUCONAZOLE TEVA Labeling Approval
04/09/2021 EPIFOAM
ANDA #086457		 SUPPL-34 HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
04/09/2021 CLOZAPINE
ANDA #090308		 SUPPL-1 CLOZAPINE BARR LABS INC Labeling Approval
04/09/2021 XOLAIR
BLA #103976		 SUPPL-5238 OMALIZUMAB GENENTECH Approval
04/09/2021 OSELTAMIVIR PHOSPHATE
ANDA #202595		 SUPPL-5 OSELTAMIVIR PHOSPHATE NATCO Labeling Approval
04/09/2021 OSELTAMIVIR PHOSPHATE
ANDA #202595		 SUPPL-9 OSELTAMIVIR PHOSPHATE NATCO Labeling Approval
04/09/2021 OSELTAMIVIR PHOSPHATE
ANDA #202595		 SUPPL-11 OSELTAMIVIR PHOSPHATE NATCO Labeling Approval
04/09/2021 LUMASON
NDA #203684		 SUPPL-9 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES BRACCO Labeling Approval
04/09/2021 NOREPINEPHRINE BITARTRATE
ANDA #211242		 SUPPL-4 NOREPINEPHRINE BITARTRATE MYLAN LABS LTD Labeling Approval
04/09/2021 IBRUTINIB
ANDA #212763		 ORIG-1 IBRUTINIB ALVOGEN PINE BROOK Tentative Approval
04/12/2021 CATAFLAM
ANDA #076561		 SUPPL-11 DICLOFENAC POTASSIUM AMICI Manufacturing (CMC) Approval
04/12/2021 LINZESS
NDA #202811		 SUPPL-17 LINACLOTIDE ABBVIE Labeling Approval
04/12/2021 BUDESONIDE
ANDA #206134		 SUPPL-1 BUDESONIDE ZYDUS PHARMS Labeling Approval
04/12/2021 BUDESONIDE
ANDA #206134		 SUPPL-4 BUDESONIDE ZYDUS PHARMS Labeling Approval
04/12/2021 BUDESONIDE
ANDA #206134		 SUPPL-6 BUDESONIDE ZYDUS PHARMS Manufacturing (CMC) Approval
04/12/2021 BENZOYL PEROXIDE AND CLINDAMYCIN PHOSPHATE
ANDA #208757		 ORIG-1 BENZOYL PEROXIDE;CLINDAMYCIN PHOSPHATE ACTAVIS LABS UT INC Tentative Approval
04/12/2021 OZEMPIC
NDA #209637		 SUPPL-8 SEMAGLUTIDE NOVO Labeling Approval
04/12/2021 DECITABINE
ANDA #212826		 ORIG-1 DECITABINE QILU PHARM HAINAN Approval
04/12/2021 ISOTRETINOIN
ANDA #213571		 ORIG-1 ISOTRETINOIN UPSHER SMITH LABS Approval
04/13/2021 PROSCAR
NDA #020180		 SUPPL-48 FINASTERIDE ORGANON Labeling Approval
04/13/2021 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-42 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-37 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Labeling Approval
04/13/2021 INDOMETHACIN
ANDA #070900		 SUPPL-23 INDOMETHACIN SUN PHARM INDUSTRIES Labeling Approval
04/13/2021 RIBAVIRIN
ANDA #077224		 SUPPL-19 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
04/13/2021 RIBAVIRIN
ANDA #077224		 SUPPL-21 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
04/13/2021 RIBAVIRIN
ANDA #077224		 SUPPL-22 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
04/13/2021 XIAFLEX
BLA #125338		 SUPPL-112 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
04/13/2021 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-19 LEVETIRACETAM HQ SPCLT PHARMA Labeling Approval
04/13/2021 CLINOLIPID 20%
NDA #204508		 SUPPL-15 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Labeling Approval
04/13/2021 TADALAFIL
ANDA #206286		 SUPPL-2 TADALAFIL AUROBINDO PHARMA LTD Labeling Approval
04/13/2021 KYLEENA
NDA #208224		 SUPPL-2 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
04/13/2021 TRULANCE
NDA #208745		 SUPPL-11 PLECANATIDE SALIX Labeling Approval
04/13/2021 IBUPROFEN
ANDA #209178		 SUPPL-6 IBUPROFEN AUROBINDO PHARMA LTD Labeling Approval
04/13/2021 PREGABALIN
ANDA #211593		 ORIG-1 PREGABALIN ALVOGEN Approval
04/13/2021 PREGABALIN
ANDA #211889		 ORIG-1 PREGABALIN SUN PHARM Approval
04/13/2021 PREGABALIN
ANDA #211948		 ORIG-1 PREGABALIN NORVIUM BIOSCIENCE Approval
04/13/2021 PREGABALIN
ANDA #213226		 ORIG-1 PREGABALIN MSN Approval
04/13/2021 CARBAMAZEPINE
ANDA #213311		 ORIG-1 CARBAMAZEPINE CSPC OUYI Approval
04/13/2021 PREGABALIN
ANDA #213313		 ORIG-1 PREGABALIN APOTEX Approval
04/13/2021 TECENTRIQ
BLA #761034		 SUPPL-41 ATEZOLIZUMAB GENENTECH INC Approval
04/13/2021 TRODELVY
BLA #761115		 SUPPL-9 SACITUZUMAB GOVITECAN-HZIY IMMUNOMEDICS INC Approval
04/14/2021 ALAWAY
NDA #021996		 SUPPL-17 KETOTIFEN FUMARATE BAUSCH AND LOMB Labeling Approval
04/14/2021 CHILDREN'S ALAWAY
NDA #021996		 SUPPL-17 KETOTIFEN FUMARATE BAUSCH AND LOMB Labeling Approval
04/14/2021 RIBAVIRIN
ANDA #079117		 SUPPL-13 RIBAVIRIN AUROBINDO PHARMA Labeling Approval
04/14/2021 RIBAVIRIN
ANDA #079117		 SUPPL-16 RIBAVIRIN AUROBINDO PHARMA Labeling Approval
04/14/2021 RIBAVIRIN
ANDA #079117		 SUPPL-17 RIBAVIRIN AUROBINDO PHARMA Labeling Approval
04/14/2021 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-44 METHADONE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
04/14/2021 BIVALIRUDIN
ANDA #090189		 SUPPL-2 BIVALIRUDIN FRESENIUS KABI USA Labeling Approval
04/14/2021 DONEPEZIL HYDROCHLORIDE
ANDA #090247		 SUPPL-3 DONEPEZIL HYDROCHLORIDE HIKMA PHARMS Labeling Approval
04/14/2021 CONTRAVE
NDA #200063		 SUPPL-20 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE NALPROPION Labeling Approval
04/14/2021 TRANEXAMIC ACID
ANDA #202755		 SUPPL-4 TRANEXAMIC ACID CHARTWELL RX Labeling Approval
04/14/2021 CLOFARABINE
ANDA #207831		 SUPPL-2 CLOFARABINE GLAND PHARMA LTD Labeling Approval
04/14/2021 ASPIRIN AND DIPYRIDAMOLE
ANDA #210318		 SUPPL-1 ASPIRIN; DIPYRIDAMOLE GLENMARK SPECLT Labeling Approval
04/14/2021 BUDESONIDE
ANDA #211922		 ORIG-1 BUDESONIDE SUN PHARM Approval
04/14/2021 POLYETHYLENE GLYCOL 3350
ANDA #214990		 ORIG-1 POLYETHYLENE GLYCOL 3350 ANNORA PHARMA Approval
04/15/2021 VFEND
NDA #021266		 SUPPL-50 VORICONAZOLE PF PRISM CV Labeling Approval
04/15/2021 VFEND
NDA #021267		 SUPPL-60 VORICONAZOLE PF PRISM CV Labeling Approval
04/15/2021 VFEND
NDA #021630		 SUPPL-39 VORICONAZOLE PF PRISM CV Labeling Approval
04/15/2021 TOBRAMYCIN SULFATE
NDA #050789		 SUPPL-12 TOBRAMYCIN SULFATE FRESENIUS KABI USA Labeling Approval
04/15/2021 ACETYLCYSTEINE
ANDA #204797		 ORIG-1 ACETYLCYSTEINE EXELA PHARMA Approval
04/15/2021 NEXTSTELLIS
NDA #214154		 ORIG-1 DROSPIRENONE; ESTETROL MAYNE PHARMA Type 1 - New Molecular Entity and Type 4 - New Combination Approval
04/16/2021 CLEVIPREX
NDA #022156		 SUPPL-7 CLEVIDIPINE CHIESI Labeling Approval
04/16/2021 AFINITOR
NDA #022334		 SUPPL-47 EVEROLIMUS NOVARTIS Labeling Approval
04/16/2021 AZACTAM
NDA #050580		 SUPPL-46 AZTREONAM BRISTOL MYERS SQUIBB Labeling Approval
04/16/2021 CABERGOLINE
ANDA #078035		 SUPPL-11 CABERGOLINE ACTAVIS LABS FL INC Labeling Approval
04/16/2021 CLOZAPINE
ANDA #090308		 SUPPL-6 CLOZAPINE BARR LABS INC Labeling Approval
04/16/2021 OPDIVO
BLA #125554		 SUPPL-91 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
04/16/2021 DYMISTA
NDA #202236		 SUPPL-13 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE MYLAN SPECIALITY LP Labeling Approval
04/16/2021 AFINITOR DISPERZ
NDA #203985		 SUPPL-20 EVEROLIMUS NOVARTIS PHARM Labeling Approval
04/16/2021 EVEKEO ODT
NDA #209905		 SUPPL-1 AMPHETAMINE SULFATE AZURITY Efficacy Approval
04/16/2021 METFORMIN HYDROCHLORIDE
ANDA #213334		 ORIG-1 METFORMIN HYDROCHLORIDE SCIEGEN PHARMS INC Approval
04/16/2021 MILRINONE LACTATE
ANDA #214380		 ORIG-1 MILRINONE LACTATE CAPLIN Approval
04/16/2021 NYVEPRIA
BLA #761111		 SUPPL-4 PEGFILGRASTIM-APGF HOSPIRA INC Approval
04/17/2021 INDOMETHACIN
ANDA #071148		 SUPPL-19 INDOMETHACIN ANI PHARMS Labeling Approval
04/17/2021 INDOMETHACIN
ANDA #071149		 SUPPL-19 INDOMETHACIN ANI PHARMS Labeling Approval
04/17/2021 FLURBIPROFEN
ANDA #074358		 SUPPL-10 FLURBIPROFEN NATCO PHARMA Labeling Approval
04/17/2021 FLURBIPROFEN
ANDA #074358		 SUPPL-11 FLURBIPROFEN NATCO PHARMA Labeling Approval
04/19/2021 DIOVAN
NDA #021283		 SUPPL-58 VALSARTAN NOVARTIS Efficacy Approval
04/19/2021 GABLOFEN
NDA #022462		 SUPPL-13 BACLOFEN PIRAMAL CRITICAL Labeling Approval
04/19/2021 SULINDAC
ANDA #072712		 SUPPL-13 SULINDAC CHARTWELL RX Labeling Approval
04/19/2021 SULINDAC
ANDA #072713		 SUPPL-13 SULINDAC CHARTWELL RX Labeling Approval
04/19/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-39 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
04/19/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-41 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
04/19/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075452		 SUPPL-44 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
04/19/2021 Xeomin
BLA #125360		 SUPPL-87 incobotulinumtoxinA MERZ PHARMS Approval
04/19/2021 Xeomin
BLA #125360		 SUPPL-88 incobotulinumtoxinA MERZ PHARMS Approval
04/19/2021 Xeomin
BLA #125360		 SUPPL-89 incobotulinumtoxinA MERZ PHARMS Approval
04/19/2021 Xeomin
BLA #125360		 SUPPL-90 incobotulinumtoxinA MERZ PHARMS Approval
04/19/2021 Xeomin
BLA #125360		 SUPPL-91 incobotulinumtoxinA MERZ PHARMS Approval
04/19/2021 INDOMETHACIN
ANDA #202706		 SUPPL-4 INDOMETHACIN JUBILANT GENERICS Labeling Approval
04/19/2021 AZELAIC ACID
ANDA #212581		 ORIG-1 AZELAIC ACID TARO PHARM INDS LTD Tentative Approval
04/19/2021 MVASI
BLA #761028		 SUPPL-6 BEVACIZUMAB-AWWB AMGEN INC Approval
04/20/2021 INFED
NDA #017441		 SUPPL-179 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
04/20/2021 PRADAXA
NDA #022512		 SUPPL-42 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
04/20/2021 FLURBIPROFEN
ANDA #075058		 SUPPL-13 FLURBIPROFEN SUN PHARM INDS INC Labeling Approval
04/20/2021 DICLOFENAC SODIUM
ANDA #075185		 SUPPL-13 DICLOFENAC SODIUM CARLSBAD Labeling Approval
04/20/2021 ELIQUIS
NDA #202155		 SUPPL-32 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
04/20/2021 SAVAYSA
NDA #206316		 SUPPL-17 EDOXABAN TOSYLATE DAIICHI SANKYO INC Labeling Approval
04/20/2021 RYDAPT
NDA #207997		 SUPPL-7 MIDOSTAURIN NOVARTIS Labeling Approval
04/20/2021 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #212396		 ORIG-1 METHYLPREDNISOLONE SODIUM SUCCINATE TIANJIN KINGYORK Approval
04/20/2021 LIDOCAINE
ANDA #212695		 ORIG-1 LIDOCAINE QUAGEN Approval
04/20/2021 NEOSTIGMINE METHYLSULFATE
ANDA #213074		 ORIG-1 NEOSTIGMINE METHYLSULFATE CAPLIN Approval
04/20/2021 FAMOTIDINE
ANDA #215043		 ORIG-1 FAMOTIDINE NOVITIUM PHARMA Approval
04/21/2021 LOTREL
NDA #020364		 SUPPL-68 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ Labeling Approval
04/21/2021 CELLCEPT
NDA #050722		 SUPPL-47 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
04/21/2021 CELLCEPT
NDA #050723		 SUPPL-47 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
04/21/2021 CELLCEPT
NDA #050758		 SUPPL-44 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO REMS Approval
04/21/2021 CELLCEPT
NDA #050759		 SUPPL-52 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
04/21/2021 MYFORTIC
NDA #050791		 SUPPL-34 MYCOPHENOLIC SODIUM NOVARTIS REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-28 MYCOPHENOLATE MOFETIL SANDOZ REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065410		 SUPPL-18 MYCOPHENOLATE MOFETIL HIKMA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065413		 SUPPL-18 MYCOPHENOLATE MOFETIL HIKMA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065416		 SUPPL-20 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-28 MYCOPHENOLATE MOFETIL SANDOZ REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065457		 SUPPL-16 MYCOPHENOLATE MOFETIL TEVA PHARMS REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-22 MYCOPHENOLATE MOFETIL TEVA PHARMS REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-28 MYCOPHENOLATE MOFETIL MYLAN REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-26 MYCOPHENOLATE MOFETIL MYLAN REMS Approval
04/21/2021 LIDOCAINE HYDROCHLORIDE
ANDA #083173		 SUPPL-45 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Labeling Approval
04/21/2021 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #084625		 SUPPL-46 LIDOCAINE HYDROCHLORIDE HIKMA Labeling Approval
04/21/2021 CHLOROPROCAINE HYDROCHLORIDE
ANDA #087447		 SUPPL-19 CHLOROPROCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090055		 SUPPL-20 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090111		 SUPPL-11 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090253		 SUPPL-20 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090456		 SUPPL-23 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090606		 SUPPL-10 MYCOPHENOLATE MOFETIL AMNEAL REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090661		 SUPPL-9 MYCOPHENOLATE MOFETIL JUBILANT CADISTA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #090762		 SUPPL-9 MYCOPHENOLATE MOFETIL JUBILANT CADISTA REMS Approval
04/21/2021 MYCOPHENOLIC SODIUM
ANDA #091248		 SUPPL-15 MYCOPHENOLIC SODIUM RK PHARMA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-23 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
04/21/2021 MYCOPHENOLIC SODIUM
ANDA #091558		 SUPPL-16 MYCOPHENOLIC SODIUM APOTEX INC REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-20 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
04/21/2021 MYCOPHENOLIC SODIUM
ANDA #202555		 SUPPL-5 MYCOPHENOLIC SODIUM ACCORD HLTHCARE REMS Approval
04/21/2021 MYCOPHENOLIC SODIUM
ANDA #202720		 SUPPL-8 MYCOPHENOLIC SODIUM TEVA PHARMS USA REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #203005		 SUPPL-16 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #203575		 SUPPL-6 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ENDO OPERATIONS REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #203859		 SUPPL-7 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYLAN LABS LTD REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043		 SUPPL-9 MYCOPHENOLATE MOFETIL HYDROCHLORIDE RISING REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #204076		 SUPPL-3 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #204077		 SUPPL-3 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204473		 SUPPL-5 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ZYDUS PHARMS REMS Approval
04/21/2021 VASOSTRICT
NDA #204485		 SUPPL-20 VASOPRESSIN ENDO OPERATIONS Manufacturing (CMC) Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #210181		 SUPPL-8 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #210370		 SUPPL-8 MYCOPHENOLATE MOFETIL VISTAPHARM REMS Approval
04/21/2021 MYCOPHENOLIC SODIUM
ANDA #211173		 SUPPL-6 MYCOPHENOLIC SODIUM CONCORD BIOTECH LTD REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #211374		 SUPPL-1 MYCOPHENOLATE MOFETIL HYDROCHLORIDE AMNEAL REMS Approval
04/21/2021 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #211443		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE APOTEX Approval
04/21/2021 MYCOPHENOLATE MOFETIL
ANDA #212087		 SUPPL-3 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD REMS Approval
04/21/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #212130		 SUPPL-2 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MEITHEAL REMS Approval
04/21/2021 DAPTOMYCIN
ANDA #212250		 ORIG-1 DAPTOMYCIN HISUN PHARM HANGZHOU Approval
04/21/2021 FOSCARNET SODIUM
ANDA #213001		 ORIG-1 FOSCARNET SODIUM GLAND PHARMA LTD Approval
04/21/2021 PROPAFENONE HYDROCHLORIDE
ANDA #214184		 ORIG-1 PROPAFENONE HYDROCHLORIDE ZYDUS LIFESCIENCES Approval
04/21/2021 MYCOPHENOLIC SODIUM
ANDA #214376		 SUPPL-1 MYCOPHENOLIC SODIUM AMTA REMS Approval
04/21/2021 DOXEPIN HYDROCHLORIDE
ANDA #215076		 ORIG-1 DOXEPIN HYDROCHLORIDE ALEMBIC Approval
04/22/2021 SAMSCA
NDA #022275		 SUPPL-17 TOLVAPTAN OTSUKA Labeling Approval
04/22/2021 CRESEMBA
NDA #207500		 SUPPL-8 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
04/22/2021 CRESEMBA
NDA #207501		 SUPPL-7 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
04/22/2021 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #213709		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ASCENT PHARMS INC Approval
04/22/2021 PROCHLORPERAZINE EDISYLATE
ANDA #214379		 ORIG-1 PROCHLORPERAZINE EDISYLATE CAPLIN Approval
04/22/2021 TROGARZO
BLA #761065		 SUPPL-11 IBALIZUMAB-UIYK THERATECHNOLOGIES Approval
04/22/2021 ULTOMIRIS
BLA #761108		 SUPPL-15 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
04/22/2021 JEMPERLI
BLA #761174		 ORIG-1 DOSTARLIMAB-GXLY GLAXOSMITHKLINE Approval
04/23/2021 NICORETTE
NDA #018612		 SUPPL-83 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
04/23/2021 NICORETTE (MINT)
NDA #018612		 SUPPL-83 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
04/23/2021 NICORETTE
NDA #020066		 SUPPL-65 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
04/23/2021 NICORETTE (MINT)
NDA #020066		 SUPPL-65 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
04/23/2021 MITOSOL
NDA #022572		 SUPPL-9 MITOMYCIN MOBIUS THERAP Labeling Approval
04/23/2021 INDOMETHACIN
ANDA #070719		 SUPPL-29 INDOMETHACIN HERITAGE PHARMA Labeling Approval
04/23/2021 INDOMETHACIN
ANDA #070756		 SUPPL-32 INDOMETHACIN HERITAGE PHARMA Labeling Approval
04/23/2021 NARATRIPTAN
ANDA #090381		 SUPPL-3 NARATRIPTAN HYDROCHLORIDE HIKMA Labeling Approval
04/23/2021 TACROLIMUS
ANDA #090509		 SUPPL-22 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
04/23/2021 TACROLIMUS
ANDA #090509		 SUPPL-23 TACROLIMUS DR REDDYS LABS LTD Labeling Approval
04/23/2021 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-28 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
04/23/2021 EPINEPHRINE (AUTOINJECTOR)
ANDA #090589		 SUPPL-11 EPINEPHRINE TEVA PHARMS USA Labeling Approval
04/23/2021 EPINEPHRINE (AUTOINJECTOR)
ANDA #090589		 SUPPL-13 EPINEPHRINE TEVA PHARMS USA Labeling Approval
04/23/2021 INDOMETHACIN
ANDA #202139		 SUPPL-3 INDOMETHACIN MYLAN Labeling Approval
04/23/2021 INDOMETHACIN
ANDA #202139		 SUPPL-4 INDOMETHACIN MYLAN Labeling Approval
04/23/2021 IRBESARTAN
ANDA #203020		 SUPPL-1 IRBESARTAN UNICHEM Labeling Approval
04/23/2021 COLCHICINE
ANDA #204711		 SUPPL-1 COLCHICINE AMNEAL PHARMS Labeling Approval
04/23/2021 INGREZZA
NDA #209241		 SUPPL-20 VALBENAZINE TOSYLATE NEUROCRINE Efficacy Approval
04/23/2021 TERIFLUNOMIDE
ANDA #209623		 SUPPL-3 TERIFLUNOMIDE MSN Labeling Approval
04/23/2021 METHOTREXATE SODIUM
ANDA #209787		 ORIG-1 METHOTREXATE SODIUM LOTUS PHARM CO LTD Approval
04/23/2021 CLOFARABINE
ANDA #210270		 SUPPL-2 CLOFARABINE NOVAST LABS Labeling Approval
04/23/2021 DICYCLOMINE HYDROCHLORIDE
ANDA #214721		 ORIG-1 DICYCLOMINE HYDROCHLORIDE NOVITIUM PHARMA Approval
04/23/2021 ZYNLONTA
BLA #761196		 ORIG-1 LONCASTUXIMAB TESIRINE-LPYL ADC Therapeutics SA Approval
04/26/2021 PANCREAZE
BLA #022523		 SUPPL-16 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIVUS INC Approval
04/26/2021 INDOMETHACIN
ANDA #070651		 SUPPL-15 INDOMETHACIN CHARTWELL MOLECULES Labeling Approval
04/26/2021 MECLOFENAMATE SODIUM
ANDA #072262		 SUPPL-6 MECLOFENAMATE SODIUM CHARTWELL RX Labeling Approval
04/26/2021 MECLOFENAMATE SODIUM
ANDA #072263		 SUPPL-7 MECLOFENAMATE SODIUM CHARTWELL RX Labeling Approval
04/26/2021 DIFLUNISAL
ANDA #074604		 SUPPL-3 DIFLUNISAL ANI PHARMS Labeling Approval
04/26/2021 ETODOLAC
ANDA #074842		 SUPPL-3 ETODOLAC CHARTWELL MOLECULES Labeling Approval
04/26/2021 DICLOFENAC POTASSIUM
ANDA #075229		 SUPPL-20 DICLOFENAC POTASSIUM RUBICON Labeling Approval
04/26/2021 GABAPENTIN
ANDA #075350		 SUPPL-67 GABAPENTIN ACTAVIS ELIZABETH Labeling Approval
04/26/2021 RIZATRIPTAN BENZOATE
ANDA #078739		 SUPPL-1 RIZATRIPTAN BENZOATE SANDOZ Labeling Approval
04/26/2021 ETODOLAC
ANDA #091134		 SUPPL-4 ETODOLAC ZYDUS PHARMS Labeling Approval
04/26/2021 INDOMETHACIN
ANDA #091240		 SUPPL-3 INDOMETHACIN HETERO LABS LTD III Labeling Approval
04/26/2021 MAGNESIUM SULFATE
ANDA #207967		 ORIG-1 MAGNESIUM SULFATE B BRAUN MEDICAL INC Approval
04/26/2021 FLUVASTATIN SODIUM
ANDA #209397		 ORIG-1 FLUVASTATIN SODIUM BEIJING Approval
04/26/2021 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #214065		 ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE ALKEM LABS LTD Approval
04/26/2021 TIOPRONIN
ANDA #214326		 ORIG-1 TIOPRONIN TEVA PHARMS USA INC Approval
04/26/2021 SKYRIZI
BLA #761105		 SUPPL-9 RISANKIZUMAB-RZAA ABBVIE INC Approval
04/26/2021 SKYRIZI
BLA #761105		 SUPPL-10 RISANKIZUMAB-RZAA ABBVIE INC Approval
04/27/2021 MIRALAX
NDA #022015		 SUPPL-40 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
04/27/2021 LORAZEPAM
ANDA #072926		 SUPPL-42 LORAZEPAM WATSON LABS Labeling Approval
04/27/2021 LORAZEPAM
ANDA #072926		 SUPPL-44 LORAZEPAM WATSON LABS Labeling Approval
04/27/2021 LORAZEPAM
ANDA #072927		 SUPPL-40 LORAZEPAM WATSON LABS Labeling Approval
04/27/2021 LORAZEPAM
ANDA #072927		 SUPPL-42 LORAZEPAM WATSON LABS Labeling Approval
04/27/2021 LORAZEPAM
ANDA #072928		 SUPPL-41 LORAZEPAM WATSON LABS Labeling Approval
04/27/2021 LORAZEPAM
ANDA #072928		 SUPPL-43 LORAZEPAM WATSON LABS Labeling Approval
04/27/2021 FLUCONAZOLE
ANDA #078423		 SUPPL-9 FLUCONAZOLE ANI PHARMS Labeling Approval
04/27/2021 FLUCONAZOLE
ANDA #078423		 SUPPL-12 FLUCONAZOLE ANI PHARMS Labeling Approval
04/27/2021 FLUCONAZOLE
ANDA #078423		 SUPPL-13 FLUCONAZOLE ANI PHARMS Labeling Approval
04/27/2021 VILAZODONE HYDROCHLORIDE
ANDA #208209		 ORIG-1 VILAZODONE HYDROCHLORIDE ACCORD HLTHCARE Approval
04/28/2021 PERCODAN
NDA #007337		 SUPPL-53 ASPIRIN; OXYCODONE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
04/28/2021 PERCODAN
NDA #007337		 SUPPL-53 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ENDO OPERATIONS Labeling Approval
04/28/2021 PERCODAN-DEMI
NDA #007337		 SUPPL-53 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ENDO OPERATIONS Labeling Approval
04/28/2021 SYNALGOS-DC
NDA #011483		 SUPPL-34 ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE SUN PHARM INDUSTRIES Labeling Approval
04/28/2021 EQUAGESIC
NDA #011702		 SUPPL-40 ASPIRIN; MEPROBAMATE SUN PHARM INDUSTRIES Labeling Approval
04/28/2021 NORGESIC
NDA #013416		 SUPPL-30 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE BAUSCH Labeling Approval
04/28/2021 NORGESIC FORTE
NDA #013416		 SUPPL-30 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE BAUSCH Labeling Approval
04/28/2021 PONSTEL
NDA #015034		 SUPPL-45 MEFENAMIC ACID AVION PHARMS Labeling Approval
04/28/2021 INDOCIN
NDA #016059		 SUPPL-101 INDOMETHACIN ZYLA LIFE SCIENCES Labeling Approval
04/28/2021 FIORINAL
NDA #017534		 SUPPL-74 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Labeling Approval
04/28/2021 NAPROSYN
NDA #017581		 SUPPL-115 NAPROXEN ATNAHS PHARMA US Labeling Approval
04/28/2021 NALFON
NDA #017604		 SUPPL-51 FENOPROFEN CALCIUM KEY THERAP Labeling Approval
04/28/2021 INDOCIN
NDA #017814		 SUPPL-44 INDOMETHACIN ZYLA LIFE SCIENCES Labeling Approval
04/28/2021 FELDENE
NDA #018147		 SUPPL-50 PIROXICAM PFIZER Labeling Approval
04/28/2021 ANAPROX
NDA #018164		 SUPPL-65 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
04/28/2021 ANAPROX DS
NDA #018164		 SUPPL-65 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
04/28/2021 INDOCIN SR
NDA #018185		 SUPPL-58 INDOMETHACIN ZYLA Labeling Approval
04/28/2021 INDOCIN
NDA #018332		 SUPPL-42 INDOMETHACIN ZYLA Labeling Approval
04/28/2021 INDOMETHACIN
NDA #018829		 SUPPL-23 INDOMETHACIN CHARTWELL MOLECULES Labeling Approval
04/28/2021 DAYPRO
NDA #018841		 SUPPL-33 OXAPROZIN PFIZER Labeling Approval
04/28/2021 INDOMETHACIN
NDA #018851		 SUPPL-28 INDOMETHACIN HERITAGE Labeling Approval
04/28/2021 INDOMETHACIN
NDA #018858		 SUPPL-47 INDOMETHACIN RISING Labeling Approval
04/28/2021 NAPROSYN
NDA #018965		 SUPPL-27 NAPROXEN ATNAHS PHARMA US Labeling Approval
04/28/2021 VOLTAREN
NDA #019201		 SUPPL-48 DICLOFENAC SODIUM NOVARTIS Labeling Approval
04/28/2021 FIORINAL W/CODEINE
NDA #019429		 SUPPL-44 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Labeling Approval
04/28/2021 FIORINAL W/CODEINE
NDA #019429		 SUPPL-45 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Labeling Approval
04/28/2021 EC-NAPROSYN
NDA #020067		 SUPPL-24 NAPROXEN ATNAHS PHARMA US Labeling Approval
04/28/2021 CATAFLAM
NDA #020142		 SUPPL-29 DICLOFENAC POTASSIUM NOVARTIS Labeling Approval
04/28/2021 VOLTAREN-XR
NDA #020254		 SUPPL-30 DICLOFENAC SODIUM NOVARTIS Labeling Approval
04/28/2021 NAPRELAN
NDA #020353		 SUPPL-38 NAPROXEN SODIUM TWI PHARMS Labeling Approval
04/28/2021 ARTHROTEC
NDA #020607		 SUPPL-38 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
04/28/2021 DAYPRO ALTA
NDA #020776		 SUPPL-10 OXAPROZIN POTASSIUM PFIZER Labeling Approval
04/28/2021 MOBIC
NDA #020938		 SUPPL-28 MELOXICAM BOEHRINGER INGELHEIM Labeling Approval
04/28/2021 CELEBREX
NDA #020998		 SUPPL-56 CELECOXIB UPJOHN Labeling Approval
04/28/2021 SOLARAZE
NDA #021005		 SUPPL-22 DICLOFENAC SODIUM FOUGERA PHARMS Labeling Approval
04/28/2021 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-74 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/28/2021 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-74 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/28/2021 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-74 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
04/28/2021 FLECTOR
NDA #021234		 SUPPL-19 DICLOFENAC EPOLAMINE IBSA Labeling Approval
04/28/2021 MELOXICAM
NDA #021530		 SUPPL-17 MELOXICAM AVONDALE PHARMS Labeling Approval
04/28/2021 TREXIMET
NDA #021926		 SUPPL-17 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE CURRAX Labeling Approval
04/28/2021 TREXIMET
NDA #021926		 SUPPL-18 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE CURRAX Labeling Approval
04/28/2021 CAMBIA
NDA #022165		 SUPPL-13 DICLOFENAC POTASSIUM ASSERTIO Labeling Approval
04/28/2021 CAMBIA
NDA #022165		 SUPPL-14 DICLOFENAC POTASSIUM ASSERTIO Labeling Approval
04/28/2021 ZYPREXA RELPREVV
NDA #022173		 SUPPL-39 OLANZAPINE PAMOATE CHEPLAPHARM REMS Approval
04/28/2021 CALDOLOR
NDA #022348		 SUPPL-18 IBUPROFEN CUMBERLAND PHARMS Labeling Approval
04/28/2021 SPRIX
NDA #022382		 SUPPL-21 KETOROLAC TROMETHAMINE ZYLA Labeling Approval
04/28/2021 NATROBA
NDA #022408		 SUPPL-8 SPINOSAD CIPHER Labeling Approval
04/28/2021 NATROBA
NDA #022408		 SUPPL-10 SPINOSAD CIPHER Efficacy Approval
04/28/2021 VIMOVO
NDA #022511		 SUPPL-26 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
04/28/2021 DUEXIS
NDA #022519		 SUPPL-13 FAMOTIDINE; IBUPROFEN HORIZON Labeling Approval
04/28/2021 CARISOPRODOL AND ASPIRIN
ANDA #040116		 SUPPL-14 ASPIRIN; CARISOPRODOL GENUS Labeling Approval
04/28/2021 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
ANDA #040118		 SUPPL-21 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE SANDOZ Labeling Approval
04/28/2021 OXYCODONE AND ASPIRIN
ANDA #040255		 SUPPL-31 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ANI PHARMS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #070045		 SUPPL-29 IBUPROFEN NORVIUM BIOSCIENCE Labeling Approval
04/28/2021 IBUPROFEN
ANDA #070057		 SUPPL-29 IBUPROFEN NORVIUM BIOSCIENCE Labeling Approval
04/28/2021 IBUPROFEN
ANDA #070329		 SUPPL-40 IBUPROFEN STRIDES PHARMA Labeling Approval
04/28/2021 IBUPROFEN
ANDA #070330		 SUPPL-40 IBUPROFEN STRIDES PHARMA Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #070624		 SUPPL-39 INDOMETHACIN RISING Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #070651		 SUPPL-16 INDOMETHACIN CHARTWELL MOLECULES Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #070673		 SUPPL-22 INDOMETHACIN SANDOZ Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #070674		 SUPPL-22 INDOMETHACIN SANDOZ Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #070719		 SUPPL-30 INDOMETHACIN HERITAGE PHARMA Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #070756		 SUPPL-33 INDOMETHACIN HERITAGE PHARMA Labeling Approval
04/28/2021 IBUPROFEN
ANDA #070986		 SUPPL-35 IBUPROFEN STRIDES PHARMA Labeling Approval
04/28/2021 MECLOFENAMATE SODIUM
ANDA #071081		 SUPPL-21 MECLOFENAMATE SODIUM MYLAN Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #071148		 SUPPL-20 INDOMETHACIN ANI PHARMS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #071149		 SUPPL-20 INDOMETHACIN ANI PHARMS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071230		 SUPPL-17 IBUPROFEN ENDO OPERATIONS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071231		 SUPPL-19 IBUPROFEN ENDO OPERATIONS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071232		 SUPPL-19 IBUPROFEN ENDO OPERATIONS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071268		 SUPPL-16 IBUPROFEN CONTRACT PHARMACAL Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071334		 SUPPL-41 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071335		 SUPPL-42 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
04/28/2021 MECLOFENAMATE SODIUM
ANDA #071469		 SUPPL-24 MECLOFENAMATE SODIUM ANI PHARMS Labeling Approval
04/28/2021 SULINDAC
ANDA #071795		 SUPPL-44 SULINDAC WATSON LABS Labeling Approval
04/28/2021 SULINDAC
ANDA #071891		 SUPPL-44 SULINDAC WATSON LABS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071935		 SUPPL-34 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
04/28/2021 IBUPROFEN
ANDA #071999		 SUPPL-21 IBUPROFEN NORVIUM BIOSCIENCE Labeling Approval
04/28/2021 IBUPROFEN
ANDA #072004		 SUPPL-17 IBUPROFEN ENDO OPERATIONS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #072169		 SUPPL-12 IBUPROFEN SANDOZ Labeling Approval
04/28/2021 MECLOFENAMATE SODIUM
ANDA #072262		 SUPPL-7 MECLOFENAMATE SODIUM CHARTWELL RX Labeling Approval
04/28/2021 MECLOFENAMATE SODIUM
ANDA #072263		 SUPPL-8 MECLOFENAMATE SODIUM CHARTWELL RX Labeling Approval
04/28/2021 FENOPROFEN CALCIUM
ANDA #072267		 SUPPL-25 FENOPROFEN CALCIUM KEY THERAP Labeling Approval
04/28/2021 FENOPROFEN CALCIUM
ANDA #072274		 SUPPL-25 FENOPROFEN CALCIUM ANI PHARMS Labeling Approval
04/28/2021 FENOPROFEN CALCIUM
ANDA #072429		 SUPPL-8 FENOPROFEN CALCIUM STRIDES PHARMA Labeling Approval
04/28/2021 SULINDAC
ANDA #072710		 SUPPL-15 SULINDAC EPIC PHARMA Labeling Approval
04/28/2021 SULINDAC
ANDA #072711		 SUPPL-16 SULINDAC EPIC PHARMA Labeling Approval
04/28/2021 SULINDAC
ANDA #072712		 SUPPL-14 SULINDAC CHARTWELL RX Labeling Approval
04/28/2021 SULINDAC
ANDA #072713		 SUPPL-14 SULINDAC CHARTWELL RX Labeling Approval
04/28/2021 SULINDAC
ANDA #073039		 SUPPL-22 SULINDAC RISING Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073290		 SUPPL-18 TOLMETIN SODIUM TEVA Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073308		 SUPPL-17 TOLMETIN SODIUM ANI PHARMS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #073314		 SUPPL-25 INDOMETHACIN COSETTE Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073392		 SUPPL-4 TOLMETIN SODIUM ANI PHARMS Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073393		 SUPPL-11 TOLMETIN SODIUM RISING Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073462		 SUPPL-6 TOLMETIN SODIUM CHARTWELL RX Labeling Approval
04/28/2021 KETOPROFEN
ANDA #073516		 SUPPL-30 KETOPROFEN TEVA Labeling Approval
04/28/2021 KETOPROFEN
ANDA #073517		 SUPPL-28 KETOPROFEN TEVA Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073519		 SUPPL-10 TOLMETIN SODIUM ANI PHARMS Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073527		 SUPPL-16 TOLMETIN SODIUM ANI PHARMS Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #073588		 SUPPL-4 TOLMETIN SODIUM CHARTWELL RX Labeling Approval
04/28/2021 DIFLUNISAL
ANDA #073673		 SUPPL-32 DIFLUNISAL TEVA Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #074002		 SUPPL-3 TOLMETIN SODIUM CHARTWELL RX Labeling Approval
04/28/2021 KETOPROFEN
ANDA #074014		 SUPPL-12 KETOPROFEN MISEMER Labeling Approval
04/28/2021 KETOPROFEN
ANDA #074035		 SUPPL-15 KETOPROFEN RISING Labeling Approval
04/28/2021 FLURBIPROFEN
ANDA #074358		 SUPPL-12 FLURBIPROFEN NATCO PHARMA Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #074399		 SUPPL-4 TOLMETIN SODIUM COSETTE Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #074464		 SUPPL-21 INDOMETHACIN SANDOZ Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #074473		 SUPPL-15 TOLMETIN SODIUM RISING Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #074514		 SUPPL-44 DICLOFENAC SODIUM ACTAVIS ELIZABETH Labeling Approval
04/28/2021 DIFLUNISAL
ANDA #074604		 SUPPL-4 DIFLUNISAL ANI PHARMS Labeling Approval
04/28/2021 ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
ANDA #074654		 SUPPL-19 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE SANDOZ Labeling Approval
04/28/2021 TOLMETIN SODIUM
ANDA #074729		 SUPPL-11 TOLMETIN SODIUM COSETTE Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #074754		 SUPPL-20 KETOROLAC TROMETHAMINE TEVA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #074761		 SUPPL-15 KETOROLAC TROMETHAMINE MYLAN Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #074802		 SUPPL-48 KETOROLAC TROMETHAMINE HOSPIRA Labeling Approval
04/28/2021 INVAGESIC
ANDA #074817		 SUPPL-3 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE SANDOZ Labeling Approval
04/28/2021 INVAGESIC FORTE
ANDA #074817		 SUPPL-3 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE SANDOZ Labeling Approval
04/28/2021 ETODOLAC
ANDA #074819		 SUPPL-30 ETODOLAC OXFORD PHARMS Labeling Approval
04/28/2021 ETODOLAC
ANDA #074839		 SUPPL-4 ETODOLAC SHREE HARI INTL Labeling Approval
04/28/2021 ETODOLAC
ANDA #074840		 SUPPL-5 ETODOLAC ANI PHARMS Labeling Approval
04/28/2021 ETODOLAC
ANDA #074841		 SUPPL-3 ETODOLAC CHARTWELL MOLECULES Labeling Approval
04/28/2021 ETODOLAC
ANDA #074842		 SUPPL-4 ETODOLAC CHARTWELL MOLECULES Labeling Approval
04/28/2021 ETODOLAC
ANDA #074844		 SUPPL-6 ETODOLAC ANI PHARMS Labeling Approval
04/28/2021 ETODOLAC
ANDA #074846		 SUPPL-9 ETODOLAC SHREE HARI INTL Labeling Approval
04/28/2021 ETODOLAC
ANDA #074903		 SUPPL-30 ETODOLAC PANGEA Labeling Approval
04/28/2021 ETODOLAC
ANDA #074932		 SUPPL-8 ETODOLAC NATCO PHARMA Labeling Approval
04/28/2021 ETODOLAC
ANDA #074942		 SUPPL-4 ETODOLAC SANDOZ Labeling Approval
04/28/2021 IBUPROFEN
ANDA #074978		 SUPPL-49 IBUPROFEN ACTAVIS MID ATLANTIC Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #074986		 SUPPL-3 DICLOFENAC SODIUM MICRO LABS Labeling Approval
04/28/2021 ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
ANDA #074988		 SUPPL-1 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE STEVENS J Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #074993		 SUPPL-39 KETOROLAC TROMETHAMINE HOSPIRA Labeling Approval
04/28/2021 ETODOLAC
ANDA #075009		 SUPPL-21 ETODOLAC TEVA Labeling Approval
04/28/2021 ETODOLAC
ANDA #075074		 SUPPL-26 ETODOLAC TARO PHARM INDS Labeling Approval
04/28/2021 ETODOLAC
ANDA #075078		 SUPPL-17 ETODOLAC TARO Labeling Approval
04/28/2021 ETODOLAC
ANDA #075104		 SUPPL-10 ETODOLAC NATCO PHARMA Labeling Approval
04/28/2021 ETODOLAC
ANDA #075126		 SUPPL-12 ETODOLAC ANI PHARMS Labeling Approval
04/28/2021 ORPHENGESIC
ANDA #075141		 SUPPL-2 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE GALT PHARMS Labeling Approval
04/28/2021 ORPHENGESIC FORTE
ANDA #075141		 SUPPL-2 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE GALT PHARMS Labeling Approval
04/28/2021 NABUMETONE
ANDA #075189		 SUPPL-31 NABUMETONE IMPAX LABS INC Labeling Approval
04/28/2021 DICLOFENAC POTASSIUM
ANDA #075219		 SUPPL-19 DICLOFENAC POTASSIUM TEVA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075222		 SUPPL-20 KETOROLAC TROMETHAMINE HIKMA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075228		 SUPPL-17 KETOROLAC TROMETHAMINE HIKMA Labeling Approval
04/28/2021 DICLOFENAC POTASSIUM
ANDA #075229		 SUPPL-23 DICLOFENAC POTASSIUM RUBICON Labeling Approval
04/28/2021 KETOPROFEN
ANDA #075270		 SUPPL-14 KETOPROFEN ACTAVIS LABS FL INC Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #075281		 SUPPL-12 DICLOFENAC SODIUM AUROBINDO PHARMA USA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075299		 SUPPL-4 KETOROLAC TROMETHAMINE HIKMA Labeling Approval
04/28/2021 DICLOFENAC POTASSIUM
ANDA #075463		 SUPPL-18 DICLOFENAC POTASSIUM RK PHARMA Labeling Approval
04/28/2021 DICLOFENAC POTASSIUM
ANDA #075582		 SUPPL-5 DICLOFENAC POTASSIUM CHARTWELL RX Labeling Approval
04/28/2021 NABUMETONE
ANDA #075590		 SUPPL-14 NABUMETONE EPIC PHARMA LLC Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075626		 SUPPL-13 KETOROLAC TROMETHAMINE APOTEX INC Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075631		 SUPPL-20 KETOROLAC TROMETHAMINE BAXTER HLTHCARE CORP Labeling Approval
04/28/2021 ETODOLAC
ANDA #075665		 SUPPL-13 ETODOLAC TEVA Labeling Approval
04/28/2021 KETOPROFEN
ANDA #075679		 SUPPL-12 KETOPROFEN MYLAN Labeling Approval
04/28/2021 IBUPROFEN
ANDA #075682		 SUPPL-18 IBUPROFEN DR REDDYS LA Labeling Approval
04/28/2021 ETODOLAC
ANDA #075696		 SUPPL-16 ETODOLAC ACTAVIS ELIZABETH Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075772		 SUPPL-8 KETOROLAC TROMETHAMINE HIKMA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #075784		 SUPPL-20 KETOROLAC TROMETHAMINE FRESENIUS KABI USA Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #075910		 SUPPL-28 DICLOFENAC SODIUM ACTAVIS ELIZABETH Labeling Approval
04/28/2021 IBUPROFEN
ANDA #076112		 SUPPL-17 IBUPROFEN DR REDDYS LABS INC Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #076152		 SUPPL-14 DICLOFENAC SODIUM AUROBINDO PHARMA USA Labeling Approval
04/28/2021 ETODOLAC
ANDA #076174		 SUPPL-14 ETODOLAC TARO Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #076201		 SUPPL-27 DICLOFENAC SODIUM DEXCEL LTD Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #076271		 SUPPL-12 KETOROLAC TROMETHAMINE SANDOZ Labeling Approval
04/28/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076604		 SUPPL-25 HYDROCODONE BITARTRATE; IBUPROFEN ACTAVIS LABS FL INC Labeling Approval
04/28/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-32 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
04/28/2021 REPREXAIN
ANDA #076642		 SUPPL-32 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
04/28/2021 IBUPROFEN
ANDA #076925		 SUPPL-47 IBUPROFEN PADAGIS US Labeling Approval
04/28/2021 IBUPROFEN
ANDA #077114		 SUPPL-14 IBUPROFEN L PERRIGO CO Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #077201		 SUPPL-4 KETOROLAC TROMETHAMINE APOTEX INC Labeling Approval
04/28/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077454		 SUPPL-7 HYDROCODONE BITARTRATE; IBUPROFEN ANI PHARMS Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #077863		 SUPPL-17 DICLOFENAC SODIUM UNIQUE Labeling Approval
04/28/2021 MELOXICAM
ANDA #077882		 SUPPL-8 MELOXICAM COREPHARMA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #078145		 SUPPL-5 KETOROLAC TROMETHAMINE LUITPOLD Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #078299		 SUPPL-8 KETOROLAC TROMETHAMINE STERISCIENCE SPECLTS Labeling Approval
04/28/2021 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078316		 SUPPL-13 IBUPROFEN; OXYCODONE HYDROCHLORIDE BARR LABS INC Labeling Approval
04/28/2021 IBUPROFEN
ANDA #078329		 SUPPL-15 IBUPROFEN STRIDES PHARMA Labeling Approval
04/28/2021 NABUMETONE
ANDA #078420		 SUPPL-6 NABUMETONE SCIEGEN PHARMS INC Labeling Approval
04/28/2021 IBUPROFEN
ANDA #078558		 SUPPL-32 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
04/28/2021 NABUMETONE
ANDA #078671		 SUPPL-20 NABUMETONE INVAGEN PHARMS Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #078737		 SUPPL-15 KETOROLAC TROMETHAMINE SUN PHARM Labeling Approval
04/28/2021 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078769		 SUPPL-32 IBUPROFEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
04/28/2021 NABUMETONE
ANDA #079093		 SUPPL-2 NABUMETONE OXFORD PHARMS Labeling Approval
04/28/2021 CARISOPRODOL AND ASPIRIN
ANDA #089594		 SUPPL-12 ASPIRIN; CARISOPRODOL CHARTWELL RX Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #090066		 SUPPL-12 DICLOFENAC SODIUM UNIQUE Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #090403		 SUPPL-6 INDOMETHACIN ZYDUS LIFESCIENCES Labeling Approval
04/28/2021 NABUMETONE
ANDA #090427		 SUPPL-2 NABUMETONE NOSTRUM LABS INC Labeling Approval
04/28/2021 NABUMETONE
ANDA #090445		 SUPPL-4 NABUMETONE ANNORA PHARMA Labeling Approval
04/28/2021 NABUMETONE
ANDA #090516		 SUPPL-4 NABUMETONE AUROBINDO PHARMA USA Labeling Approval
04/28/2021 IBUPROFEN
ANDA #090796		 SUPPL-4 IBUPROFEN MARKSANS PHARMA Labeling Approval
04/28/2021 NABUMETONE
ANDA #091083		 SUPPL-11 NABUMETONE WATSON LABS Labeling Approval
04/28/2021 ETODOLAC
ANDA #091134		 SUPPL-8 ETODOLAC ZYDUS PHARMS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #091240		 SUPPL-9 INDOMETHACIN HETERO LABS LTD III Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #091276		 SUPPL-6 INDOMETHACIN GLENMARK PHARMS LTD Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #091549		 SUPPL-13 INDOMETHACIN AMNEAL PHARMS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #091625		 SUPPL-14 IBUPROFEN GRANULES Labeling Approval
04/28/2021 OXYCODONE AND ASPIRIN
ANDA #091670		 SUPPL-8 ASPIRIN; OXYCODONE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
04/28/2021 CAMPATH
BLA #103948		 SUPPL-5182 ALEMTUZUMAB GENZYME Approval
04/28/2021 LEMTRADA
BLA #103948		 SUPPL-5182 ALEMTUZUMAB GENZYME Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #201155		 SUPPL-2 KETOROLAC TROMETHAMINE STERISCIENCE SPECLTS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #201807		 SUPPL-5 INDOMETHACIN HETERO LABS LTD III Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #202027		 SUPPL-9 DICLOFENAC SODIUM APOTEX Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #202139		 SUPPL-5 INDOMETHACIN MYLAN Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #202393		 SUPPL-2 DICLOFENAC SODIUM TWI PHARMS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #202572		 SUPPL-3 INDOMETHACIN WATSON LABS INC Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #202706		 SUPPL-9 INDOMETHACIN JUBILANT GENERICS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #202711		 SUPPL-2 INDOMETHACIN ZYDUS PHARMS Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #202769		 SUPPL-4 DICLOFENAC SODIUM PAI HOLDINGS PHARM Labeling Approval
04/28/2021 DIFLUNISAL
ANDA #202845		 SUPPL-7 DIFLUNISAL HERITAGE PHARMA Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #202852		 SUPPL-3 DICLOFENAC SODIUM WATSON LABS INC Labeling Approval
04/28/2021 NABUMETONE
ANDA #203166		 SUPPL-3 NABUMETONE LGM PHARMA Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #203242		 SUPPL-6 KETOROLAC TROMETHAMINE FRESENIUS KABI USA Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #203501		 SUPPL-3 INDOMETHACIN GLENMARK PHARMS LTD Labeling Approval
04/28/2021 DIFLUNISAL
ANDA #203547		 SUPPL-1 DIFLUNISAL ZYDUS PHARMS Labeling Approval
04/28/2021 INJECTAFER
NDA #203565		 SUPPL-14 FERRIC CARBOXYMALTOSE AM REGENT Efficacy Approval
04/28/2021 IBUPROFEN
ANDA #204062		 SUPPL-3 IBUPROFEN SUNSHINE Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #204132		 SUPPL-6 DICLOFENAC SODIUM LUPIN LTD Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #204216		 SUPPL-10 KETOROLAC TROMETHAMINE GLAND Labeling Approval
04/28/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #204575		 SUPPL-7 HYDROCODONE BITARTRATE; IBUPROFEN AUROLIFE PHARMA LLC Labeling Approval
04/28/2021 ZORVOLEX
NDA #204592		 SUPPL-13 DICLOFENAC ZYLA Labeling Approval
04/28/2021 PENNSAID
NDA #204623		 SUPPL-11 DICLOFENAC SODIUM HORIZON Labeling Approval
04/28/2021 TIVORBEX
NDA #204768		 SUPPL-8 INDOMETHACIN GENUS Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #204853		 SUPPL-2 INDOMETHACIN NOVAST LABS Labeling Approval
04/28/2021 BUPRENORPHINE
ANDA #204937		 SUPPL-2 BUPRENORPHINE WATSON LABS TEVA Labeling Approval
04/28/2021 BUPRENORPHINE
ANDA #204937		 SUPPL-3 BUPRENORPHINE WATSON LABS TEVA Labeling Approval
04/28/2021 BUPRENORPHINE
ANDA #204937		 SUPPL-4 BUPRENORPHINE WATSON LABS TEVA Labeling Approval
04/28/2021 BUPRENORPHINE
ANDA #204937		 SUPPL-6 BUPRENORPHINE WATSON LABS TEVA Labeling Approval
04/28/2021 YOSPRALA
NDA #205103		 SUPPL-7 ASPIRIN; OMEPRAZOLE GENUS LIFESCIENCES Labeling Approval
04/28/2021 INDOMETHACIN
ANDA #205215		 SUPPL-5 INDOMETHACIN JUBILANT GENERICS Labeling Approval
04/28/2021 IBUPROFEN
ANDA #205647		 SUPPL-8 IBUPROFEN PAI HOLDINGS PHARM Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #205878		 SUPPL-2 DICLOFENAC SODIUM NOVEL LABS INC Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #206411		 SUPPL-2 DICLOFENAC SODIUM ZYDUS LIFESCIENCES Labeling Approval
04/28/2021 LICART
NDA #206976		 SUPPL-7 DICLOFENAC EPOLAMINE IBSA INST BIO Labeling Approval
04/28/2021 VIVLODEX
NDA #207233		 SUPPL-4 MELOXICAM ICEUTICA OPERATIONS Labeling Approval
04/28/2021 DICLOFENAC SODIUM
ANDA #208786		 SUPPL-1 DICLOFENAC SODIUM RISING Labeling Approval
04/28/2021 ETODOLAC
ANDA #208834		 SUPPL-5 ETODOLAC AMNEAL PHARMS CO Labeling Approval
04/28/2021 IBUPROFEN
ANDA #209178		 SUPPL-7 IBUPROFEN AUROBINDO PHARMA LTD Labeling Approval
04/28/2021 ETODOLAC
ANDA #209888		 SUPPL-2 ETODOLAC EDENBRIDGE PHARMS Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #209900		 SUPPL-3 KETOROLAC TROMETHAMINE BAXTER HLTHCARE CORP Labeling Approval
04/28/2021 CONSENSI
NDA #210045		 SUPPL-9 AMLODIPINE BESYLATE; CELECOXIB PURPLE BIOTECH Labeling Approval
04/28/2021 ANJESO
NDA #210583		 SUPPL-1 MELOXICAM BAUDAX Labeling Approval
04/28/2021 KETOROLAC TROMETHAMINE
ANDA #210616		 SUPPL-1 KETOROLAC TROMETHAMINE CHARTWELL RX Labeling Approval
04/28/2021 QMIIZ ODT
NDA #211210		 SUPPL-2 MELOXICAM TERSERA Labeling Approval
04/28/2021 SODIUM CHLORIDE 14.6%
ANDA #212070		 ORIG-1 SODIUM CHLORIDE FRESENIUS KABI USA Approval
04/28/2021 SODIUM CHLORIDE 23.4%
ANDA #212070		 ORIG-1 SODIUM CHLORIDE FRESENIUS KABI USA Approval
04/28/2021 ELYXYB
NDA #212157		 SUPPL-2 CELECOXIB SCILEX PHARMS Labeling Approval
04/28/2021 SODIUM CHLORIDE 23.4%
ANDA #212248		 ORIG-1 SODIUM CHLORIDE FRESENIUS KABI USA Approval
04/28/2021 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #212433		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE ENCUBE Approval
04/28/2021 DROXIDOPA
ANDA #213033		 ORIG-1 DROXIDOPA BIONPHARMA Approval
04/28/2021 IBUPROFEN
ANDA #213794		 SUPPL-2 IBUPROFEN AUROBINDO PHARMA LTD Labeling Approval
04/29/2021 METRO I.V. IN PLASTIC CONTAINER
NDA #018900		 SUPPL-38 METRONIDAZOLE B BRAUN Labeling Approval
04/29/2021 ZOFRAN
NDA #020007		 SUPPL-48 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/29/2021 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-48 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/29/2021 ZOFRAN
NDA #020103		 SUPPL-37 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/29/2021 ZOFRAN
NDA #020605		 SUPPL-21 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/29/2021 ZOFRAN ODT
NDA #020781		 SUPPL-21 ONDANSETRON SANDOZ Labeling Approval
04/29/2021 DICLOFENAC SODIUM
ANDA #074376		 SUPPL-42 DICLOFENAC SODIUM CHARTWELL RX Labeling Approval
04/29/2021 DICLOFENAC SODIUM
ANDA #074394		 SUPPL-51 DICLOFENAC SODIUM CHARTWELL RX Labeling Approval
04/29/2021 DICLOFENAC SODIUM
ANDA #075185		 SUPPL-15 DICLOFENAC SODIUM CARLSBAD Labeling Approval
04/29/2021 DICLOFENAC SODIUM
ANDA #075185		 SUPPL-16 DICLOFENAC SODIUM CARLSBAD Labeling Approval
04/29/2021 NABUMETONE
ANDA #075280		 SUPPL-25 NABUMETONE CHARTWELL RX Labeling Approval
04/29/2021 ETODOLAC
ANDA #075419		 SUPPL-13 ETODOLAC APOTEX Labeling Approval
04/29/2021 DICLOFENAC SODIUM
ANDA #075492		 SUPPL-14 DICLOFENAC SODIUM VPNA Labeling Approval
04/29/2021 ETODOLAC
ANDA #076004		 SUPPL-13 ETODOLAC APOTEX INC Labeling Approval
04/29/2021 KETOROLAC TROMETHAMINE
ANDA #076209		 SUPPL-5 KETOROLAC TROMETHAMINE AMPHASTAR PHARM Labeling Approval
04/29/2021 CATAFLAM
ANDA #076561		 SUPPL-12 DICLOFENAC POTASSIUM AMICI Labeling Approval
04/29/2021 KETOROLAC TROMETHAMINE
ANDA #077942		 SUPPL-5 KETOROLAC TROMETHAMINE WOCKHARDT Labeling Approval
04/29/2021 KETOROLAC TROMETHAMINE
ANDA #077943		 SUPPL-3 KETOROLAC TROMETHAMINE WOCKHARDT BIO AG Labeling Approval
04/29/2021 METHOCARBAMOL AND ASPIRIN
ANDA #081145		 SUPPL-1 ASPIRIN; METHOCARBAMOL STEVENS J Labeling Approval
04/29/2021 KETOROLAC TROMETHAMINE
ANDA #091065		 SUPPL-5 KETOROLAC TROMETHAMINE SAGENT PHARMS INC Labeling Approval
04/29/2021 INDOMETHACIN
ANDA #091401		 SUPPL-4 INDOMETHACIN SUN PHARM INDS INC Labeling Approval
04/29/2021 INDOMETHACIN
ANDA #091401		 SUPPL-5 INDOMETHACIN SUN PHARM INDS INC Labeling Approval
04/29/2021 MORPHINE SULFATE
NDA #202515		 SUPPL-25 MORPHINE SULFATE HOSPIRA INC Efficacy Approval
04/29/2021 MORPHINE SULFATE
ANDA #202861		 ORIG-1 MORPHINE SULFATE INTL MEDICATION SYS Approval
04/29/2021 KETOROLAC TROMETHAMINE
ANDA #203242		 SUPPL-1 KETOROLAC TROMETHAMINE FRESENIUS KABI USA Labeling Approval
04/29/2021 LIDOCAINE
ANDA #205882		 ORIG-1 LIDOCAINE NAL PHARM Approval
04/29/2021 DICLOFENAC SODIUM
ANDA #206116		 SUPPL-7 DICLOFENAC SODIUM AMNEAL PHARMS Labeling Approval
04/29/2021 GABAPENTIN
ANDA #206402		 SUPPL-3 GABAPENTIN ALKEM LABS LTD Labeling Approval
04/29/2021 GABAPENTIN
ANDA #206402		 SUPPL-5 GABAPENTIN ALKEM LABS LTD Labeling Approval
04/29/2021 GABAPENTIN
ANDA #206402		 SUPPL-14 GABAPENTIN ALKEM LABS LTD Labeling Approval
04/29/2021 GABAPENTIN
ANDA #206402		 SUPPL-17 GABAPENTIN ALKEM LABS LTD Labeling Approval
04/29/2021 XHANCE
NDA #209022		 SUPPL-10 FLUTICASONE PROPIONATE OPTINOSE US INC Manufacturing (CMC) Approval
04/29/2021 XHANCE
NDA #209022		 SUPPL-11 FLUTICASONE PROPIONATE OPTINOSE US INC Labeling Approval
04/29/2021 KLOXXADO
NDA #212045		 ORIG-1 NALOXONE HYDROCHLORIDE HIKMA Type 5 - New Formulation or New Manufacturer Approval
04/29/2021 SILDENAFIL CITRATE
ANDA #213814		 ORIG-1 SILDENAFIL CITRATE APPCO Approval
04/30/2021 BACTRIM
NDA #017377		 SUPPL-83 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 BACTRIM DS
NDA #017377		 SUPPL-83 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 BICNU
NDA #017422		 SUPPL-62 CARMUSTINE AVET LIFESCIENCES Manufacturing (CMC) Approval
04/30/2021 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018826		 SUPPL-47 DOPAMINE HYDROCHLORIDE HOSPIRA Labeling Approval
04/30/2021 FERRIPROX
NDA #021825		 SUPPL-8 DEFERIPRONE CHIESI Efficacy Approval
04/30/2021 CARISOPRODOL AND ASPIRIN
ANDA #040832		 SUPPL-1 ASPIRIN; CARISOPRODOL NOVAST LABS Labeling Approval
04/30/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #065401		 SUPPL-16 VANCOMYCIN HYDROCHLORIDE MEDIMETRIKS PHARMS Labeling Approval
04/30/2021 IBUPROFEN
ANDA #070079		 SUPPL-38 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 IBUPROFEN
ANDA #070080		 SUPPL-40 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 INDOMETHACIN
ANDA #070900		 SUPPL-24 INDOMETHACIN SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 IBUPROFEN
ANDA #071448		 SUPPL-19 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 SULINDAC
ANDA #072050		 SUPPL-40 SULINDAC SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 SULINDAC
ANDA #072051		 SUPPL-45 SULINDAC SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 FENOPROFEN CALCIUM
ANDA #072902		 SUPPL-19 FENOPROFEN CALCIUM SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 SULINDAC
ANDA #072973		 SUPPL-24 SULINDAC ANI PHARMS Labeling Approval
04/30/2021 TOLMETIN SODIUM
ANDA #073311		 SUPPL-18 TOLMETIN SODIUM SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 GEMFIBROZIL
ANDA #075034		 SUPPL-31 GEMFIBROZIL APOTEX Labeling Approval
04/30/2021 FLURBIPROFEN
ANDA #075058		 SUPPL-14 FLURBIPROFEN SUN PHARM INDS INC Labeling Approval
04/30/2021 DICLOFENAC POTASSIUM
ANDA #075470		 SUPPL-11 DICLOFENAC POTASSIUM SUN PHARM INDUSTRIES Labeling Approval
04/30/2021 HYDROCODONE
ANDA #077723		 SUPPL-30 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
04/30/2021 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-30 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
04/30/2021 CANDESARTAN CILEXETIL
ANDA #078702		 SUPPL-2 CANDESARTAN CILEXETIL MYLAN Labeling Approval
04/30/2021 CANDESARTAN CILEXETIL
ANDA #078702		 SUPPL-6 CANDESARTAN CILEXETIL MYLAN Labeling Approval
04/30/2021 AZELASTINE HYDROCHLORIDE
ANDA #090176		 SUPPL-4 AZELASTINE HYDROCHLORIDE BIONPHARMA Labeling Approval
04/30/2021 AZELASTINE HYDROCHLORIDE
ANDA #090176		 SUPPL-7 AZELASTINE HYDROCHLORIDE BIONPHARMA Labeling Approval
04/30/2021 AZELASTINE HYDROCHLORIDE
ANDA #091409		 SUPPL-1 AZELASTINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
04/30/2021 FARXIGA
NDA #202293		 SUPPL-24 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
04/30/2021 AUBAGIO
NDA #202992		 SUPPL-13 TERIFLUNOMIDE SANOFI AVENTIS US Efficacy Approval
04/30/2021 AUBAGIO
NDA #202992		 SUPPL-15 TERIFLUNOMIDE SANOFI AVENTIS US Labeling Approval
04/30/2021 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #203466		 SUPPL-1 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE ZYDUS LIFESCIENCES Labeling Approval
04/30/2021 METFORMIN HYDROCHLORIDE
ANDA #203686		 SUPPL-6 METFORMIN HYDROCHLORIDE ZYDUS HLTHCARE Labeling Approval
04/30/2021 METFORMIN HYDROCHLORIDE
ANDA #203686		 SUPPL-9 METFORMIN HYDROCHLORIDE ZYDUS HLTHCARE Labeling Approval
04/30/2021 METFORMIN HYDROCHLORIDE
ANDA #203686		 SUPPL-10 METFORMIN HYDROCHLORIDE ZYDUS HLTHCARE Labeling Approval
04/30/2021 CANDESARTAN CILEXETIL
ANDA #203813		 SUPPL-16 CANDESARTAN CILEXETIL MACLEODS PHARMS LTD Labeling Approval
04/30/2021 DICLOFENAC SODIUM
ANDA #203818		 SUPPL-7 DICLOFENAC SODIUM TARO Labeling Approval
04/30/2021 DICLOFENAC SODIUM
ANDA #206715		 SUPPL-2 DICLOFENAC SODIUM RISING Labeling Approval
04/30/2021 AZELASTINE HYDROCHLORIDE
ANDA #207411		 SUPPL-1 AZELASTINE HYDROCHLORIDE SOMERSET THERAPS LLC Labeling Approval
04/30/2021 AZELASTINE HYDROCHLORIDE
ANDA #207411		 SUPPL-2 AZELASTINE HYDROCHLORIDE SOMERSET THERAPS LLC Labeling Approval
04/30/2021 FERRIPROX
NDA #208030		 SUPPL-5 DEFERIPRONE CHIESI Efficacy Approval
04/30/2021 AZELASTINE HYDROCHLORIDE
ANDA #208156		 SUPPL-2 AZELASTINE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
04/30/2021 IBUPROFEN
ANDA #209204		 SUPPL-8 IBUPROFEN TARO Labeling Approval
04/30/2021 FERRIPROX
NDA #212269		 SUPPL-1 DEFERIPRONE CHIESI Efficacy Approval
04/30/2021 BACLOFEN
ANDA #212378		 SUPPL-1 BACLOFEN ANDAS 5 HOLDING Manufacturing (CMC) Approval
04/30/2021 ATAZANAVIR SULFATE
ANDA #212579		 ORIG-1 ATAZANAVIR SULFATE LAURUS Approval
04/30/2021 METHOCARBAMOL
ANDA #212623		 ORIG-1 METHOCARBAMOL ALLIED Approval
04/30/2021 RYBELSUS
NDA #213051		 SUPPL-6 SEMAGLUTIDE NOVO Manufacturing (CMC) Approval
04/30/2021 PALBOCICLIB
ANDA #213107		 ORIG-1 PALBOCICLIB SUN PHARM INDS LTD Tentative Approval
04/30/2021 EVRYSDI
NDA #213535		 SUPPL-1 RISDIPLAM GENENTECH INC Labeling Approval
04/30/2021 TROSPIUM CHLORIDE
ANDA #214760		 ORIG-1 TROSPIUM CHLORIDE AMTA Approval
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