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 |