06/01/2022 |
TOPROL-XL NDA #019962 |
SUPPL-49 |
METOPROLOL SUCCINATE |
TOPROL |
Labeling |
Approval |
06/01/2022 |
DYANAVEL XR NDA #208147 |
SUPPL-12 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
06/01/2022 |
DYANAVEL XR 10 NDA #210526 |
SUPPL-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
06/01/2022 |
DYANAVEL XR 15 NDA #210526 |
SUPPL-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
06/01/2022 |
DYANAVEL XR 20 NDA #210526 |
SUPPL-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
06/01/2022 |
DYANAVEL XR 5 NDA #210526 |
SUPPL-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
06/01/2022 |
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #211360 |
ORIG-1 |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
AUROBINDO PHARMA |
|
Approval |
06/01/2022 |
ACCRUFER NDA #212320 |
SUPPL-13 |
FERRIC MALTOL |
SHIELD TX |
Labeling |
Approval |
06/01/2022 |
BRIVARACETAM ANDA #214831 |
ORIG-1 |
BRIVARACETAM |
ANNORA PHARMA |
|
Tentative Approval |
06/02/2022 |
CREON BLA #020725 |
SUPPL-28 |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
ABBVIE |
|
Approval |
06/02/2022 |
BELRAPZO NDA #205580 |
SUPPL-12 |
BENDAMUSTINE HYDROCHLORIDE |
EAGLE PHARMS |
Labeling |
Approval |
06/02/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #212756 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
AVEVA |
|
Approval |
06/02/2022 |
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NDA #214313 |
SUPPL-1 |
NOREPINEPHRINE BITARTRATE |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
06/02/2022 |
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NDA #214313 |
SUPPL-2 |
NOREPINEPHRINE BITARTRATE |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
06/02/2022 |
TIOPRONIN ANDA #216198 |
ORIG-1 |
TIOPRONIN |
PAR PHARM INC |
|
Approval |
06/02/2022 |
TESTOSTERONE CYPIONATE NDA #216318 |
ORIG-1 |
TESTOSTERONE CYPIONATE |
SLAYBACK PHARMA LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/03/2022 |
KETALAR NDA #016812 |
SUPPL-51 |
KETAMINE HYDROCHLORIDE |
PAR STERILE PRODUCTS |
Labeling |
Approval |
06/03/2022 |
ACETAMINOPHEN NDA #206968 |
ORIG-1 |
ACETAMINOPHEN |
HIKMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/03/2022 |
MESALAMINE ANDA #207271 |
SUPPL-1 |
MESALAMINE |
MYLAN |
Labeling |
Approval |
06/03/2022 |
MESALAMINE ANDA #207271 |
SUPPL-3 |
MESALAMINE |
MYLAN |
Labeling |
Approval |
06/03/2022 |
MESALAMINE ANDA #208954 |
SUPPL-2 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
06/03/2022 |
MESALAMINE ANDA #214242 |
SUPPL-1 |
MESALAMINE |
ALKEM LABS LTD |
Labeling |
Approval |
06/03/2022 |
ADAPALENE AND BENZOYL PEROXIDE ANDA #214553 |
ORIG-1 |
ADAPALENE; BENZOYL PEROXIDE |
ZYDUS PHARMS |
|
Approval |
06/03/2022 |
FAMOTIDINE ANDA #216441 |
ORIG-1 |
FAMOTIDINE |
ZYDUS PHARMS |
|
Approval |
06/03/2022 |
TRODELVY BLA #761115 |
SUPPL-23 |
SACITUZUMAB GOVITECAN-HZIY |
IMMUNOMEDICS INC |
|
Approval |
06/03/2022 |
RIABNI BLA #761140 |
SUPPL-1 |
RITUXIMAB-ARRX |
AMGEN INC |
|
Approval |
06/06/2022 |
CELLCEPT NDA #050722 |
SUPPL-49 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050722 |
SUPPL-51 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050723 |
SUPPL-49 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050723 |
SUPPL-51 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050758 |
SUPPL-47 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050758 |
SUPPL-49 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050759 |
SUPPL-54 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
CELLCEPT NDA #050759 |
SUPPL-56 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Efficacy |
Approval |
06/06/2022 |
HYDROCHLOROTHIAZIDE ANDA #075640 |
SUPPL-23 |
HYDROCHLOROTHIAZIDE |
MYLAN |
Labeling |
Approval |
06/06/2022 |
HYDROCHLOROTHIAZIDE ANDA #075907 |
SUPPL-15 |
HYDROCHLOROTHIAZIDE |
PRINSTON INC |
Labeling |
Approval |
06/06/2022 |
BUPROPION HYDROCHLORIDE ANDA #075914 |
SUPPL-31 |
BUPROPION HYDROCHLORIDE |
IMPAX LABS |
Labeling |
Approval |
06/06/2022 |
LUTATHERA NDA #208700 |
SUPPL-20 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Labeling |
Approval |
06/06/2022 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #209672 |
SUPPL-3 |
VALGANCICLOVIR HYDROCHLORIDE |
CIPLA |
Labeling |
Approval |
06/06/2022 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #209672 |
SUPPL-5 |
VALGANCICLOVIR HYDROCHLORIDE |
CIPLA |
Labeling |
Approval |
06/06/2022 |
VORICONAZOLE ANDA #211099 |
SUPPL-1 |
VORICONAZOLE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/06/2022 |
VORICONAZOLE ANDA #211099 |
SUPPL-2 |
VORICONAZOLE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/06/2022 |
VORICONAZOLE ANDA #211099 |
SUPPL-4 |
VORICONAZOLE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/06/2022 |
VORICONAZOLE ANDA #211099 |
SUPPL-7 |
VORICONAZOLE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/06/2022 |
VORICONAZOLE ANDA #211099 |
SUPPL-8 |
VORICONAZOLE |
GLAND PHARMA LTD |
Labeling |
Approval |
06/06/2022 |
LEUPROLIDE ACETATE ANDA #212963 |
ORIG-1 |
LEUPROLIDE ACETATE |
EUGIA PHARMA |
|
Approval |
06/06/2022 |
POTASSIUM CHLORIDE ANDA #213062 |
ORIG-1 |
POTASSIUM CHLORIDE |
WES PHARMA INC |
|
Approval |
06/06/2022 |
LEQVIO NDA #214012 |
SUPPL-2 |
INCLISIRAN SODIUM |
NOVARTIS |
Labeling |
Approval |
06/06/2022 |
GANIRELIX ACETATE ANDA #214996 |
ORIG-1 |
GANIRELIX ACETATE |
MEITHEAL |
|
Approval |
06/06/2022 |
AMITRIPTYLINE HYDROCHLORIDE ANDA #216243 |
ORIG-1 |
AMITRIPTYLINE HYDROCHLORIDE |
CHEMISTRY HLTH |
|
Approval |
06/06/2022 |
HEMLIBRA BLA #761083 |
SUPPL-15 |
EMICIZUMAB |
GENENTECH INC |
|
Approval |
06/07/2022 |
LANTUS BLA #021081 |
SUPPL-76 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
06/07/2022 |
LANTUS SOLOSTAR BLA #021081 |
SUPPL-76 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
06/07/2022 |
FINASTERIDE ANDA #076511 |
SUPPL-24 |
FINASTERIDE |
TEVA |
Labeling |
Approval |
06/07/2022 |
FINASTERIDE ANDA #076511 |
SUPPL-28 |
FINASTERIDE |
TEVA |
Labeling |
Approval |
06/07/2022 |
OFLOXACIN ANDA #076848 |
SUPPL-1 |
OFLOXACIN |
SANDOZ |
Labeling |
Approval |
06/07/2022 |
NADOLOL ANDA #201893 |
SUPPL-3 |
NADOLOL |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
06/07/2022 |
LENALIDOMIDE ANDA #209348 |
SUPPL-2 |
LENALIDOMIDE |
DR REDDYS |
Labeling |
Approval |
06/07/2022 |
NAPROXEN ANDA #215776 |
ORIG-1 |
NAPROXEN |
HETERO LABS LTD III |
|
Approval |
06/07/2022 |
SORAFENIB TOSYLATE ANDA #216073 |
ORIG-1 |
SORAFENIB TOSYLATE |
DR REDDYS |
|
Approval |
06/07/2022 |
IVACAFTOR ANDA #216074 |
ORIG-1 |
IVACAFTOR |
LUPIN LTD |
|
Tentative Approval |
06/07/2022 |
DUPIXENT BLA #761055 |
SUPPL-42 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
06/08/2022 |
ESCITALOPRAM OXALATE ANDA #202280 |
SUPPL-8 |
ESCITALOPRAM OXALATE |
JUBILANT CADISTA |
Labeling |
Approval |
06/08/2022 |
ESCITALOPRAM OXALATE ANDA #202280 |
SUPPL-13 |
ESCITALOPRAM OXALATE |
JUBILANT CADISTA |
Labeling |
Approval |
06/08/2022 |
ESCITALOPRAM OXALATE ANDA #202280 |
SUPPL-19 |
ESCITALOPRAM OXALATE |
JUBILANT CADISTA |
Labeling |
Approval |
06/08/2022 |
NEURACEQ NDA #204677 |
SUPPL-21 |
FLORBETABEN F-18 |
LIFE MOLECULAR |
Manufacturing (CMC) |
Approval |
06/08/2022 |
NEOSTIGMINE METHYLSULFATE ANDA #207042 |
SUPPL-9 |
NEOSTIGMINE METHYLSULFATE |
HIKMA |
Labeling |
Approval |
06/08/2022 |
NEOSTIGMINE METHYLSULFATE ANDA #209135 |
SUPPL-2 |
NEOSTIGMINE METHYLSULFATE |
DR REDDYS |
Labeling |
Approval |
06/08/2022 |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 ANDA #215371 |
ORIG-1 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
FRESENIUS KABI USA |
|
Approval |
06/08/2022 |
GUANFACINE HYDROCHLORIDE ANDA #216399 |
ORIG-1 |
GUANFACINE HYDROCHLORIDE |
TWI PHARMS |
|
Approval |
06/09/2022 |
CEFUROXIME AXETIL ANDA #065069 |
SUPPL-17 |
CEFUROXIME AXETIL |
APOTEX |
Labeling |
Approval |
06/09/2022 |
FLUCONAZOLE ANDA #076351 |
SUPPL-15 |
FLUCONAZOLE |
MYLAN |
Labeling |
Approval |
06/09/2022 |
FLUCONAZOLE ANDA #076351 |
SUPPL-16 |
FLUCONAZOLE |
MYLAN |
Labeling |
Approval |
06/09/2022 |
PANTOPRAZOLE SODIUM ANDA #078281 |
SUPPL-32 |
PANTOPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
06/09/2022 |
EPOPROSTENOL SODIUM ANDA #078396 |
SUPPL-21 |
EPOPROSTENOL SODIUM |
MEITHEAL |
Labeling |
Approval |
06/09/2022 |
EPOPROSTENOL SODIUM ANDA #078396 |
SUPPL-22 |
EPOPROSTENOL SODIUM |
MEITHEAL |
Labeling |
Approval |
06/09/2022 |
EPOPROSTENOL SODIUM ANDA #078396 |
SUPPL-23 |
EPOPROSTENOL SODIUM |
MEITHEAL |
Labeling |
Approval |
06/09/2022 |
XIAFLEX BLA #125338 |
SUPPL-127 |
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM |
AUXILIUM PHARMS |
|
Approval |
06/09/2022 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-22 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/09/2022 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-23 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/09/2022 |
FLUCONAZOLE ANDA #208963 |
SUPPL-10 |
FLUCONAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
06/09/2022 |
FLUCONAZOLE ANDA #208963 |
SUPPL-11 |
FLUCONAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
06/09/2022 |
BRIMONIDINE TARTRATE ANDA #209158 |
SUPPL-1 |
BRIMONIDINE TARTRATE |
PADAGIS ISRAEL |
Manufacturing (CMC) |
Approval |
06/09/2022 |
PANTOPRAZOLE SODIUM ANDA #211368 |
SUPPL-3 |
PANTOPRAZOLE SODIUM |
INGENUS PHARMS LLC |
Labeling |
Approval |
06/09/2022 |
PANTOPRAZOLE SODIUM ANDA #211368 |
SUPPL-4 |
PANTOPRAZOLE SODIUM |
INGENUS PHARMS LLC |
Labeling |
Approval |
06/09/2022 |
METFORMIN HYDROCHLORIDE ANDA #212681 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
PRINSTON INC |
|
Approval |
06/09/2022 |
URSODIOL ANDA #213504 |
SUPPL-1 |
URSODIOL |
STRIDES PHARMA |
Labeling |
Approval |
06/09/2022 |
NALOXONE HYDROCHLORIDE ANDA #213843 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
MYLAN LABS LTD |
|
Approval |
06/09/2022 |
IBUPROFEN ANDA #214071 |
ORIG-1 |
IBUPROFEN |
STRIDES PHARMA |
|
Approval |
06/09/2022 |
BRIVARACETAM ANDA #214748 |
ORIG-1 |
BRIVARACETAM |
SUNSHINE |
|
Approval |
06/09/2022 |
LIDOCAINE HYDROCHLORIDE ANDA #215132 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
AFAXYS |
|
Approval |
06/09/2022 |
DASATINIB ANDA #216261 |
ORIG-1 |
DASATINIB |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
06/09/2022 |
BYOOVIZ BLA #761202 |
SUPPL-4 |
RANIBIZUMAB-NUNA |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
06/10/2022 |
VIRAMUNE NDA #020636 |
SUPPL-52 |
NEVIRAPINE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
06/10/2022 |
VIRAMUNE NDA #020933 |
SUPPL-43 |
NEVIRAPINE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
06/10/2022 |
BYETTA NDA #021773 |
SUPPL-46 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
06/10/2022 |
BYETTA NDA #021773 |
SUPPL-47 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
06/10/2022 |
BYDUREON NDA #022200 |
SUPPL-33 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
06/10/2022 |
BYDUREON PEN NDA #022200 |
SUPPL-33 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
06/10/2022 |
VICTOZA NDA #022341 |
SUPPL-37 |
LIRAGLUTIDE RECOMBINANT |
NOVO NORDISK INC |
Labeling |
Approval |
06/10/2022 |
VICTOZA NDA #022341 |
SUPPL-38 |
LIRAGLUTIDE RECOMBINANT |
NOVO NORDISK INC |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #076972 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #076972 |
SUPPL-10 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #076972 |
SUPPL-17 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #076972 |
SUPPL-18 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #076974 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #076974 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #076974 |
SUPPL-16 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #076974 |
SUPPL-17 |
ONDANSETRON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/10/2022 |
LAMOTRIGINE ANDA #077633 |
SUPPL-35 |
LAMOTRIGINE |
ZYDUS PHARMS USA |
Labeling |
Approval |
06/10/2022 |
LAMOTRIGINE ANDA #077633 |
SUPPL-37 |
LAMOTRIGINE |
ZYDUS PHARMS USA |
Labeling |
Approval |
06/10/2022 |
LAMOTRIGINE ANDA #078009 |
SUPPL-28 |
LAMOTRIGINE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
06/10/2022 |
LAMOTRIGINE ANDA #078009 |
SUPPL-29 |
LAMOTRIGINE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
06/10/2022 |
TRULICITY BLA #125469 |
SUPPL-46 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
06/10/2022 |
TRULICITY BLA #125469 |
SUPPL-52 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
06/10/2022 |
VIRAMUNE XR NDA #201152 |
SUPPL-14 |
NEVIRAPINE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-17 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-18 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-19 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-20 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN; HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-17 |
IRBESARTAN; HYDROCHLOROTHIAZIDE |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN; HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-18 |
IRBESARTAN; HYDROCHLOROTHIAZIDE |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN; HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-19 |
IRBESARTAN; HYDROCHLOROTHIAZIDE |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
IRBESARTAN; HYDROCHLOROTHIAZIDE ANDA #201524 |
SUPPL-20 |
IRBESARTAN; HYDROCHLOROTHIAZIDE |
LUPIN LTD |
Labeling |
Approval |
06/10/2022 |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER ANDA #208122 |
SUPPL-11 |
SODIUM CHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
06/10/2022 |
ADLYXIN BLA #208471 |
SUPPL-5 |
LIXISENATIDE |
SANOFI-AVENTIS US |
|
Approval |
06/10/2022 |
XULTOPHY 100/3.6 BLA #208583 |
SUPPL-18 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
|
Approval |
06/10/2022 |
XULTOPHY 100/3.6 BLA #208583 |
SUPPL-19 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
|
Approval |
06/10/2022 |
SOLIQUA 100/33 BLA #208673 |
SUPPL-12 |
INSULIN GLARGINE; LIXISENATIDE |
SANOFI-AVENTIS US |
|
Approval |
06/10/2022 |
PEMETREXED DITROMETHAMINE NDA #208746 |
ORIG-1 |
PEMETREXED DITROMETHAMINE |
HOSPIRA |
Type 3 - New Dosage Form |
Approval |
06/10/2022 |
RUBRACA NDA #209115 |
SUPPL-11 |
RUCAPARIB CAMSYLATE |
ZR PHARMA |
Efficacy |
Approval |
06/10/2022 |
BYDUREON BCISE NDA #209210 |
SUPPL-21 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
06/10/2022 |
TADALAFIL ANDA #209654 |
SUPPL-21 |
TADALAFIL |
AJANTA PHARMA LTD |
Labeling |
Approval |
06/10/2022 |
MAYZENT NDA #209884 |
SUPPL-10 |
SIPONIMOD |
NOVARTIS |
Labeling |
Approval |
06/10/2022 |
TIZANIDINE HYDROCHLORIDE ANDA #212196 |
SUPPL-1 |
TIZANIDINE HYDROCHLORIDE |
ALKEM LABS LTD |
Labeling |
Approval |
06/10/2022 |
NALOXONE HYDROCHLORIDE ANDA #212300 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
HIKMA |
|
Approval |
06/10/2022 |
RYBELSUS NDA #213051 |
SUPPL-11 |
SEMAGLUTIDE |
NOVO |
Labeling |
Approval |
06/10/2022 |
TIZANIDINE HYDROCHLORIDE ANDA #213223 |
SUPPL-3 |
TIZANIDINE HYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
06/10/2022 |
TIZANIDINE HYDROCHLORIDE ANDA #213544 |
SUPPL-1 |
TIZANIDINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/10/2022 |
Nitrogen, NF NDA #217499 |
ORIG-1 |
Nitrogen |
ABSOLUTE AIR, LLC |
|
Approval |
06/10/2022 |
OXYGEN, USP NDA #217500 |
ORIG-1 |
OXYGEN |
ABSOLUTE AIR, LLC |
|
Approval |
06/13/2022 |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER NDA #019904 |
SUPPL-21 |
POTASSIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
06/13/2022 |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER NDA #019904 |
SUPPL-21 |
POTASSIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
06/13/2022 |
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER NDA #019904 |
SUPPL-21 |
POTASSIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
06/13/2022 |
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER NDA #019904 |
SUPPL-21 |
POTASSIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090279 |
SUPPL-12 |
BUPRENORPHINE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091149 |
SUPPL-16 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #200265 |
SUPPL-15 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #200265 |
SUPPL-16 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #200265 |
SUPPL-17 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #200265 |
SUPPL-18 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #200265 |
SUPPL-19 |
VORICONAZOLE |
SANDOZ INC |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201066 |
SUPPL-14 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201760 |
SUPPL-20 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201760 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #203503 |
SUPPL-5 |
VORICONAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #203503 |
SUPPL-6 |
VORICONAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #203503 |
SUPPL-7 |
VORICONAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #203503 |
SUPPL-8 |
VORICONAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #203503 |
SUPPL-9 |
VORICONAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205601 |
SUPPL-6 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #206181 |
SUPPL-22 |
VORICONAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #206181 |
SUPPL-23 |
VORICONAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #206747 |
SUPPL-9 |
VORICONAZOLE |
CADILA |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #206747 |
SUPPL-10 |
VORICONAZOLE |
CADILA |
Labeling |
Approval |
06/13/2022 |
VORICONAZOLE ANDA #206747 |
SUPPL-12 |
VORICONAZOLE |
CADILA |
Labeling |
Approval |
06/13/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #207276 |
SUPPL-10 |
BUPRENORPHINE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
06/13/2022 |
OLUMIANT NDA #207924 |
SUPPL-7 |
BARICITINIB |
ELI LILLY AND CO |
Efficacy |
Approval |
06/13/2022 |
LUTATHERA NDA #208700 |
SUPPL-19 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Efficacy |
Approval |
06/13/2022 |
LUTATHERA NDA #208700 |
SUPPL-23 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Labeling |
Approval |
06/13/2022 |
PIRFENIDONE ANDA #212600 |
ORIG-1 |
PIRFENIDONE |
SANDOZ |
|
Approval |
06/13/2022 |
AMVUTTRA NDA #215515 |
ORIG-1 |
VUTRISIRAN SODIUM |
ALNYLAM PHARMS INC |
Type 1 - New Molecular Entity |
Approval |
06/13/2022 |
PROCHLORPERAZINE MALEATE ANDA #216202 |
ORIG-1 |
PROCHLORPERAZINE MALEATE |
NOVITIUM PHARMA |
|
Approval |
06/14/2022 |
DIFFERIN NDA #020380 |
SUPPL-21 |
ADAPALENE |
GALDERMA LABS LP |
Labeling |
Approval |
06/14/2022 |
GALANTAMINE HYDROBROMIDE ANDA #079028 |
SUPPL-11 |
GALANTAMINE HYDROBROMIDE |
WATSON LABS |
Labeling |
Approval |
06/14/2022 |
GALANTAMINE HYDROBROMIDE ANDA #079028 |
SUPPL-13 |
GALANTAMINE HYDROBROMIDE |
WATSON LABS |
Labeling |
Approval |
06/14/2022 |
GALANTAMINE HYDROBROMIDE ANDA #079028 |
SUPPL-14 |
GALANTAMINE HYDROBROMIDE |
WATSON LABS |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090360 |
SUPPL-19 |
BUPRENORPHINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090819 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091422 |
SUPPL-37 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091422 |
SUPPL-41 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/14/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #091483 |
SUPPL-11 |
ONDANSETRON HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203136 |
SUPPL-35 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203326 |
SUPPL-21 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #206953 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
06/14/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207000 |
SUPPL-16 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
06/14/2022 |
CANAGLIFLOZIN ANDA #210451 |
ORIG-1 |
CANAGLIFLOZIN |
TEVA PHARMS USA |
|
Tentative Approval |
06/14/2022 |
BUPROPION HYDROCHLORIDE ANDA #211020 |
SUPPL-9 |
BUPROPION HYDROCHLORIDE |
GRAVITI PHARMS |
Labeling |
Approval |
06/14/2022 |
BUPROPION HYDROCHLORIDE ANDA #211020 |
SUPPL-12 |
BUPROPION HYDROCHLORIDE |
GRAVITI PHARMS |
Labeling |
Approval |
06/14/2022 |
ENOXAPARIN SODIUM ANDA #214856 |
ORIG-1 |
ENOXAPARIN SODIUM |
NANJING KING-FRIEND |
|
Approval |
06/14/2022 |
CLORAZEPATE DIPOTASSIUM ANDA #215566 |
ORIG-1 |
CLORAZEPATE DIPOTASSIUM |
COREPHARMA |
|
Approval |
06/14/2022 |
SILIQ BLA #761032 |
SUPPL-10 |
BRODALUMAB |
VALEANT LUXEMBOURG |
|
Approval |
06/15/2022 |
NAROPIN NDA #020533 |
SUPPL-38 |
ROPIVACAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/15/2022 |
EXEMESTANE ANDA #077431 |
SUPPL-10 |
EXEMESTANE |
HIKMA |
Labeling |
Approval |
06/15/2022 |
LAMOTRIGINE ANDA #078134 |
SUPPL-10 |
LAMOTRIGINE |
HIKMA PHARMS |
Labeling |
Approval |
06/15/2022 |
LAMOTRIGINE ANDA #078134 |
SUPPL-11 |
LAMOTRIGINE |
HIKMA PHARMS |
Labeling |
Approval |
06/15/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #201633 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-3 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-5 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-6 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-7 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-10 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-11 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-12 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
VORICONAZOLE ANDA #205034 |
SUPPL-13 |
VORICONAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
06/15/2022 |
SAXENDA NDA #206321 |
SUPPL-15 |
LIRAGLUTIDE RECOMBINANT |
NOVO |
Labeling |
Approval |
06/15/2022 |
VENCLEXTA NDA #208573 |
SUPPL-27 |
VENETOCLAX |
ABBVIE |
Labeling |
Approval |
06/15/2022 |
EXEMESTANE ANDA #210323 |
SUPPL-5 |
EXEMESTANE |
CIPLA |
Labeling |
Approval |
06/15/2022 |
BUPROPION HYDROCHLORIDE ANDA #211020 |
SUPPL-11 |
BUPROPION HYDROCHLORIDE |
GRAVITI PHARMS |
Manufacturing (CMC) |
Approval |
06/15/2022 |
EXEMESTANE ANDA #211031 |
SUPPL-3 |
EXEMESTANE |
BRECKENRIDGE |
Labeling |
Approval |
06/15/2022 |
FINTEPLA NDA #212102 |
SUPPL-5 |
FENFLURAMINE HYDROCHLORIDE |
UCB INC |
Labeling |
Approval |
06/15/2022 |
VERAPAMIL HYDROCHLORIDE ANDA #214653 |
ORIG-1 |
VERAPAMIL HYDROCHLORIDE |
MANKIND PHARMA |
|
Approval |
06/15/2022 |
BREXAFEMME NDA #214900 |
SUPPL-1 |
IBREXAFUNGERP CITRATE |
SCYNEXIS |
Labeling |
Approval |
06/15/2022 |
SOLIFENACIN SUCCINATE ANDA #215761 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
ANNORA PHARMA |
|
Approval |
06/16/2022 |
FERAHEME NDA #022180 |
SUPPL-25 |
FERUMOXYTOL |
COVIS |
Labeling |
Approval |
06/16/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090622 |
SUPPL-33 |
BUPRENORPHINE HYDROCHLORIDE |
ETHYPHARM |
Labeling |
Approval |
06/16/2022 |
POLYETHYLENE GLYCOL 3350 ANDA #090685 |
SUPPL-14 |
POLYETHYLENE GLYCOL 3350 |
PERRIGO R AND D |
Manufacturing (CMC) |
Approval |
06/16/2022 |
DEXLANSOPRAZOLE ANDA #202294 |
SUPPL-6 |
DEXLANSOPRAZOLE |
PAR PHARM INC |
Manufacturing (CMC) |
Approval |
06/16/2022 |
JUXTAPID NDA #203858 |
SUPPL-24 |
LOMITAPIDE MESYLATE |
CHIESI |
REMS |
Approval |
06/16/2022 |
QUETIAPINE FUMARATE ANDA #204316 |
ORIG-1 |
QUETIAPINE FUMARATE |
HETERO LABS LTD V |
|
Approval |
06/16/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #204431 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ETHYPHARM USA CORP |
Labeling |
Approval |
06/16/2022 |
FLUNISOLIDE ANDA #207802 |
ORIG-1 |
FLUNISOLIDE |
RICONPHARMA LLC |
|
Approval |
06/16/2022 |
LINACLOTIDE ANDA #211255 |
ORIG-1 |
LINACLOTIDE |
ACTAVIS LABS FL INC |
|
Tentative Approval |
06/16/2022 |
ZULRESSO NDA #211371 |
SUPPL-7 |
BREXANOLONE |
SAGE THERAP |
Efficacy |
Approval |
06/16/2022 |
GALLIUM GA 68 GOZETOTIDE NDA #212642 |
SUPPL-2 |
GALLIUM GA-68 GOZETOTIDE |
UNIV CA LOS ANGELES |
Labeling |
Approval |
06/16/2022 |
GALLIUM GA 68 GOZETOTIDE NDA #212643 |
SUPPL-2 |
GALLIUM GA-68 GOZETOTIDE |
UNIV OF CA SAN FRAN |
Labeling |
Approval |
06/16/2022 |
CLORAZEPATE DIPOTASSIUM ANDA #213730 |
ORIG-1 |
CLORAZEPATE DIPOTASSIUM |
NOVITIUM PHARMA |
|
Approval |
06/16/2022 |
IMCIVREE NDA #213793 |
SUPPL-1 |
SETMELANOTIDE ACETATE |
RHYTHM |
Efficacy |
Approval |
06/16/2022 |
SKYRIZI BLA #761105 |
SUPPL-16 |
RISANKIZUMAB-RZAA |
ABBVIE INC |
|
Approval |
06/16/2022 |
SKYRIZI BLA #761262 |
ORIG-1 |
RISANKIZUMAB-RZAA |
ABBVIE INC |
|
Approval |
06/17/2022 |
BUPRENEX NDA #018401 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
SUBUTEX NDA #020732 |
SUPPL-27 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
SUBUTEX NDA #020732 |
SUPPL-28 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
SUBOXONE NDA #020733 |
SUPPL-31 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
SUBOXONE NDA #020733 |
SUPPL-32 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
BUTRANS NDA #021306 |
SUPPL-39 |
BUPRENORPHINE |
PURDUE PHARMA LP |
Labeling |
Approval |
06/17/2022 |
SUBOXONE NDA #022410 |
SUPPL-46 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
SUBOXONE NDA #022410 |
SUPPL-47 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
SUMATRIPTAN SUCCINATE ANDA #078327 |
SUPPL-16 |
SUMATRIPTAN SUCCINATE |
AUROBINDO PHARMA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #078633 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #078633 |
SUPPL-28 |
BUPRENORPHINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-9 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-10 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-13 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-14 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-15 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-16 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
QUETIAPINE FUMARATE ANDA #078679 |
SUPPL-17 |
QUETIAPINE FUMARATE |
SANDOZ |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090279 |
SUPPL-13 |
BUPRENORPHINE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090279 |
SUPPL-17 |
BUPRENORPHINE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090622 |
SUPPL-34 |
BUPRENORPHINE HYDROCHLORIDE |
ETHYPHARM |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090622 |
SUPPL-36 |
BUPRENORPHINE HYDROCHLORIDE |
ETHYPHARM |
Labeling |
Approval |
06/17/2022 |
LEVETIRACETAM ANDA #090767 |
SUPPL-7 |
LEVETIRACETAM |
RISING |
Labeling |
Approval |
06/17/2022 |
LEVETIRACETAM ANDA #090767 |
SUPPL-8 |
LEVETIRACETAM |
RISING |
Labeling |
Approval |
06/17/2022 |
LEVETIRACETAM ANDA #090767 |
SUPPL-9 |
LEVETIRACETAM |
RISING |
Labeling |
Approval |
06/17/2022 |
LEVETIRACETAM ANDA #090767 |
SUPPL-11 |
LEVETIRACETAM |
RISING |
Labeling |
Approval |
06/17/2022 |
LEVETIRACETAM ANDA #090767 |
SUPPL-12 |
LEVETIRACETAM |
RISING |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090819 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090819 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091149 |
SUPPL-18 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091149 |
SUPPL-20 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091422 |
SUPPL-43 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091422 |
SUPPL-45 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
06/17/2022 |
ENBREL BLA #103795 |
SUPPL-5590 |
ETANERCEPT |
IMMUNEX |
|
Approval |
06/17/2022 |
ENTYVIO BLA #125476 |
SUPPL-46 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201066 |
SUPPL-16 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201066 |
SUPPL-18 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
06/17/2022 |
TINIDAZOLE ANDA #201172 |
SUPPL-3 |
TINIDAZOLE |
HIKMA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #201633 |
SUPPL-20 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #201633 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201760 |
SUPPL-22 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #201760 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203136 |
SUPPL-37 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203136 |
SUPPL-40 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203326 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203326 |
SUPPL-25 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/17/2022 |
ZUBSOLV NDA #204242 |
SUPPL-21 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
OREXO US INC |
Labeling |
Approval |
06/17/2022 |
ZUBSOLV NDA #204242 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
OREXO US INC |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #204431 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ETHYPHARM USA CORP |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #204431 |
SUPPL-26 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ETHYPHARM USA CORP |
Labeling |
Approval |
06/17/2022 |
PROBUPHINE NDA #204442 |
SUPPL-12 |
BUPRENORPHINE HYDROCHLORIDE |
TITAN PHARMS |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205022 |
SUPPL-12 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205022 |
SUPPL-14 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
06/17/2022 |
TRANEXAMIC ACID ANDA #205228 |
SUPPL-3 |
TRANEXAMIC ACID |
ZYDUS PHARMS |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205601 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205601 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
06/17/2022 |
BUNAVAIL NDA #205637 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
06/17/2022 |
BUNAVAIL NDA #205637 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #206953 |
SUPPL-8 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #206953 |
SUPPL-10 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207000 |
SUPPL-21 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207000 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #207276 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE ANDA #207276 |
SUPPL-13 |
BUPRENORPHINE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
06/17/2022 |
BELBUCA NDA #207932 |
SUPPL-19 |
BUPRENORPHINE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
06/17/2022 |
BELBUCA NDA #207932 |
SUPPL-20 |
BUPRENORPHINE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
06/17/2022 |
CASSIPA NDA #208042 |
SUPPL-5 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
06/17/2022 |
CASSIPA NDA #208042 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #209069 |
SUPPL-5 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
WES PHARMA INC |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #209069 |
SUPPL-8 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
WES PHARMA INC |
Labeling |
Approval |
06/17/2022 |
SUBLOCADE NDA #209819 |
SUPPL-20 |
BUPRENORPHINE |
INDIVIOR |
Labeling |
Approval |
06/17/2022 |
APIXABAN ANDA #209898 |
SUPPL-1 |
APIXABAN |
INDOCO |
Labeling |
Approval |
06/17/2022 |
APIXABAN ANDA #209898 |
SUPPL-2 |
APIXABAN |
INDOCO |
Labeling |
Approval |
06/17/2022 |
TEGSEDI NDA #211172 |
SUPPL-10 |
INOTERSEN SODIUM |
AKCEA THERAPS |
Labeling |
Approval |
06/17/2022 |
TADLIQ NDA #214522 |
ORIG-1 |
TADALAFIL |
CMP DEV LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #214930 |
SUPPL-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ALKEM LABS LTD |
Labeling |
Approval |
06/17/2022 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #214930 |
SUPPL-4 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ALKEM LABS LTD |
Labeling |
Approval |
06/17/2022 |
PHEBURANE NDA #216513 |
ORIG-1 |
SODIUM PHENYLBUTYRATE |
MEDUNIK |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/17/2022 |
HADLIMA BLA #761059 |
SUPPL-4 |
ADALIMUMAB-BWWD |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
06/21/2022 |
JANUVIA NDA #021995 |
SUPPL-50 |
SITAGLIPTIN PHOSPHATE |
MERCK SHARP DOHME |
Labeling |
Approval |
06/21/2022 |
JANUMET NDA #022044 |
SUPPL-52 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Labeling |
Approval |
06/21/2022 |
KEYTRUDA BLA #125514 |
SUPPL-131 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
06/21/2022 |
JANUMET XR NDA #202270 |
SUPPL-26 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Labeling |
Approval |
06/21/2022 |
STEGLUJAN NDA #209805 |
SUPPL-11 |
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Labeling |
Approval |
06/21/2022 |
MAYZENT NDA #209884 |
SUPPL-11 |
SIPONIMOD |
NOVARTIS |
Labeling |
Approval |
06/21/2022 |
CARMUSTINE ANDA #211011 |
ORIG-1 |
CARMUSTINE |
INGENUS PHARMS LLC |
|
Approval |
06/21/2022 |
NALOXONE HYDROCHLORIDE ANDA #211951 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
PADAGIS ISRAEL |
|
Approval |
06/21/2022 |
IMATINIB MESYLATE ANDA #212135 |
ORIG-1 |
IMATINIB MESYLATE |
QILU PHARM HAINAN |
|
Approval |
06/21/2022 |
APIXABAN ANDA #213903 |
ORIG-1 |
APIXABAN |
ZHEJIANG YONGNING PHARMACEUTICAL CO LTD |
|
Tentative Approval |
06/22/2022 |
APOKYN NDA #021264 |
SUPPL-21 |
APOMORPHINE HYDROCHLORIDE |
MDD US |
Labeling |
Approval |
06/22/2022 |
TIROSINT NDA #021924 |
SUPPL-21 |
LEVOTHYROXINE SODIUM |
IBSA |
Manufacturing (CMC) |
Approval |
06/22/2022 |
DOXYCYCLINE ANDA #065356 |
SUPPL-11 |
DOXYCYCLINE |
SUN PHARM INDS LTD |
Labeling |
Approval |
06/22/2022 |
DOXYCYCLINE ANDA #065356 |
SUPPL-13 |
DOXYCYCLINE |
SUN PHARM INDS LTD |
Labeling |
Approval |
06/22/2022 |
DOXYCYCLINE ANDA #065356 |
SUPPL-15 |
DOXYCYCLINE |
SUN PHARM INDS LTD |
Labeling |
Approval |
06/22/2022 |
SUMATRIPTAN SUCCINATE ANDA #078327 |
SUPPL-17 |
SUMATRIPTAN SUCCINATE |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
06/22/2022 |
TAFINLAR NDA #202806 |
SUPPL-22 |
DABRAFENIB MESYLATE |
NOVARTIS |
Efficacy |
Approval |
06/22/2022 |
MEKINIST NDA #204114 |
SUPPL-24 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Efficacy |
Approval |
06/22/2022 |
ADAPALENE AND BENZOYL PEROXIDE ANDA #209641 |
ORIG-1 |
ADAPALENE; BENZOYL PEROXIDE |
ACTAVIS LABS UT INC |
|
Approval |
06/22/2022 |
VIGABATRIN ANDA #210042 |
ORIG-1 |
VIGABATRIN |
AMNEAL PHARMS |
|
Approval |
06/22/2022 |
PIPERACILLIN AND TAZOBACTAM ANDA #212287 |
SUPPL-6 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
06/22/2022 |
CARGLUMIC ACID ANDA #213395 |
ORIG-1 |
CARGLUMIC ACID |
NAVINTA LLC |
|
Approval |
06/22/2022 |
CARGLUMIC ACID ANDA #213729 |
SUPPL-1 |
CARGLUMIC ACID |
NOVITIUM PHARMA |
Manufacturing (CMC) |
Approval |
06/22/2022 |
PEMETREXED DISODIUM NDA #214218 |
ORIG-1 |
PEMETREXED DISODIUM |
HOSPIRA |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/22/2022 |
ERLOTINIB HYDROCHLORIDE ANDA #216342 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
06/23/2022 |
PREVACID 24 HR NDA #022327 |
SUPPL-30 |
LANSOPRAZOLE |
PERRIGO PHARMA INTL |
Labeling |
Approval |
06/23/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #076960 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/23/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #076960 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/23/2022 |
LAMOTRIGINE ANDA #078443 |
SUPPL-2 |
LAMOTRIGINE |
MYLAN LABS LTD |
Labeling |
Approval |
06/23/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #078776 |
SUPPL-14 |
ONDANSETRON HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
06/23/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #078776 |
SUPPL-15 |
ONDANSETRON HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
06/23/2022 |
ONDANSETRON HYDROCHLORIDE ANDA #091342 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
06/23/2022 |
TRANEXAMIC ACID ANDA #091657 |
SUPPL-10 |
TRANEXAMIC ACID |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
06/23/2022 |
URSODIOL ANDA #200826 |
SUPPL-9 |
URSODIOL |
IMPAX LABS INC |
Labeling |
Approval |
06/23/2022 |
CABAZITAXEL ANDA #207619 |
ORIG-1 |
CABAZITAXEL |
BRECKENRIDGE |
|
Approval |
06/23/2022 |
BUPROPION HYDROCHLORIDE ANDA #211347 |
SUPPL-9 |
BUPROPION HYDROCHLORIDE |
YICHANG HUMANWELL |
Labeling |
Approval |
06/23/2022 |
RELEXXII NDA #216117 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
OSMOTICA PHARM US |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/23/2022 |
TRIENTINE HYDROCHLORIDE ANDA #216356 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
HETERO LABS LTD III |
|
Approval |
06/24/2022 |
NITROMIST NDA #021780 |
SUPPL-8 |
NITROGLYCERIN |
EVUS |
Labeling |
Approval |
06/24/2022 |
QSYMIA NDA #022580 |
SUPPL-21 |
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
VIVUS |
Efficacy |
Approval |
06/24/2022 |
AMOXICILLIN ANDA #207471 |
ORIG-1 |
AMOXICILLIN |
MICRO LABS |
|
Approval |
06/24/2022 |
ABIRATERONE ACETATE ANDA #212206 |
ORIG-1 |
ABIRATERONE ACETATE |
TEVA PHARMS USA |
|
Approval |
06/24/2022 |
TIMOLOL MALEATE ANDA #214645 |
ORIG-1 |
TIMOLOL MALEATE |
GLAND PHARMA LTD |
|
Approval |
06/24/2022 |
VEKLURY NDA #214787 |
SUPPL-15 |
REMDESIVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
06/24/2022 |
VIGPODER ANDA #214961 |
ORIG-1 |
VIGABATRIN |
PYROS PHARMS |
|
Approval |
06/24/2022 |
DOXEPIN HYDROCHLORIDE ANDA #215113 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
MSN |
|
Approval |
06/24/2022 |
ESOMEPRAZOLE MAGNESIUM ANDA #216349 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
GRAVITI PHARMS |
|
Approval |
06/27/2022 |
HUMULIN R BLA #018780 |
SUPPL-180 |
INSULIN HUMAN |
LILLY |
|
Approval |
06/27/2022 |
HUMULIN R BLA #018780 |
SUPPL-180 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
06/27/2022 |
HUMULIN R KWIKPEN BLA #018780 |
SUPPL-180 |
INSULIN HUMAN |
LILLY |
|
Approval |
06/27/2022 |
HUMULIN R PEN BLA #018780 |
SUPPL-180 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
06/27/2022 |
HUMULIN N BLA #018781 |
SUPPL-193 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
06/27/2022 |
HUMULIN 70/30 BLA #019717 |
SUPPL-174 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
06/27/2022 |
HUMULIN 70/30 PEN BLA #019717 |
SUPPL-174 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
06/27/2022 |
LUBIPROSTONE ANDA #201442 |
ORIG-1 |
LUBIPROSTONE |
ANCHEN PHARMS |
|
Approval |
06/27/2022 |
OLMESARTAN MEDOXOMIL ANDA #203012 |
SUPPL-6 |
OLMESARTAN MEDOXOMIL |
ALEMBIC |
Labeling |
Approval |
06/27/2022 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #204750 |
SUPPL-8 |
VALGANCICLOVIR HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/27/2022 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #204750 |
SUPPL-10 |
VALGANCICLOVIR HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
06/27/2022 |
RIVAROXABAN ANDA #212220 |
ORIG-1 |
RIVAROXABAN |
MYLAN PHARMS INC |
|
Tentative Approval |
06/27/2022 |
XCOPRI NDA #212839 |
SUPPL-6 |
CENOBAMATE |
SK LIFE |
Labeling |
Approval |
06/27/2022 |
XCOPRI NDA #212839 |
SUPPL-7 |
CENOBAMATE |
SK LIFE |
Labeling |
Approval |
06/27/2022 |
TRANYLCYPROMINE SULFATE ANDA #213503 |
ORIG-1 |
TRANYLCYPROMINE SULFATE |
CROSSMEDIKA SA |
|
Approval |
06/27/2022 |
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM ANDA #214201 |
ORIG-1 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
ANDA REPOSITORY |
|
Approval |
06/28/2022 |
NAROPIN NDA #020533 |
SUPPL-44 |
ROPIVACAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/28/2022 |
NASONEX NDA #020762 |
SUPPL-56 |
MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
06/28/2022 |
KABIVEN IN PLASTIC CONTAINER NDA #200656 |
SUPPL-14 |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
FRESENIUS KABI USA |
Labeling |
Approval |
06/28/2022 |
PERIKABIVEN IN PLASTIC CONTAINER NDA #200656 |
SUPPL-14 |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
FRESENIUS KABI USA |
Labeling |
Approval |
06/28/2022 |
TRAMADOL HYDROCHLORIDE ANDA #202075 |
SUPPL-4 |
TRAMADOL HYDROCHLORIDE |
ACI |
Labeling |
Approval |
06/28/2022 |
CISATRACURIUM BESYLATE ANDA #203078 |
ORIG-1 |
CISATRACURIUM BESYLATE |
HIKMA |
|
Approval |
06/28/2022 |
OLMESARTAN MEDOXOMIL ANDA #204798 |
SUPPL-6 |
OLMESARTAN MEDOXOMIL |
AUROBINDO PHARMA |
Labeling |
Approval |
06/28/2022 |
DILTIAZEM HYDROCHLORIDE ANDA #211596 |
SUPPL-1 |
DILTIAZEM HYDROCHLORIDE |
EDENBRIDGE PHARMS |
Manufacturing (CMC) |
Approval |
06/28/2022 |
PRIMIDONE ANDA #214896 |
ORIG-1 |
PRIMIDONE |
RUBICON |
|
Approval |
06/28/2022 |
BUPROPION HYDROCHLORIDE ANDA #215568 |
SUPPL-2 |
BUPROPION HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
06/29/2022 |
HALOPERIDOL ANDA #070278 |
SUPPL-38 |
HALOPERIDOL |
MYLAN |
Manufacturing (CMC) |
Approval |
06/29/2022 |
PALIPERIDONE ANDA #208643 |
ORIG-1 |
PALIPERIDONE |
LUPIN LTD |
|
Approval |
06/29/2022 |
LACOSAMIDE ANDA #209465 |
ORIG-1 |
LACOSAMIDE |
ZYDUS PHARMS |
|
Approval |
06/29/2022 |
ORTIKOS NDA #211929 |
SUPPL-8 |
BUDESONIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
06/29/2022 |
ENALAPRIL MALEATE ANDA #212894 |
ORIG-1 |
ENALAPRIL MALEATE |
AMNEAL |
|
Approval |
06/29/2022 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #213306 |
SUPPL-1 |
VALGANCICLOVIR HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
06/29/2022 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #213306 |
SUPPL-3 |
VALGANCICLOVIR HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
06/29/2022 |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 ANDA #215370 |
ORIG-1 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
FRESENIUS KABI USA |
|
Approval |
06/29/2022 |
VENLAFAXINE BESYLATE NDA #215429 |
ORIG-1 |
VENLAFAXINE BESYLATE |
ALMATICA |
Type 2 - New Active Ingredient and Type 3 - New Dosage Form |
Approval |
06/29/2022 |
VENLAFAXINE BESYLATE NDA #215429 |
ORIG-2 |
VENLAFAXINE BESYLATE |
ALMATICA |
Type 2 - New Active Ingredient and Type 3 - New Dosage Form |
Approval |
06/29/2022 |
DROSPIRENONE NDA #216285 |
ORIG-1 |
DROSPIRENONE |
EXELTIS USA INC |
Type 3 - New Dosage Form |
Approval |
06/30/2022 |
AUGMENTIN ES-600 NDA #050755 |
SUPPL-24 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
US ANTIBIOTICS |
Labeling |
Approval |
06/30/2022 |
LOSARTAN POTASSIUM ANDA #076958 |
SUPPL-17 |
LOSARTAN POTASSIUM |
TEVA |
Labeling |
Approval |
06/30/2022 |
RAMIPRIL ANDA #077626 |
SUPPL-25 |
RAMIPRIL |
LUPIN |
Labeling |
Approval |
06/30/2022 |
RAMIPRIL ANDA #078832 |
SUPPL-17 |
RAMIPRIL |
ZYDUS PHARMS USA |
Labeling |
Approval |
06/30/2022 |
LAMOTRIGINE ANDA #078947 |
SUPPL-37 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
06/30/2022 |
LAMOTRIGINE ANDA #078947 |
SUPPL-38 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
06/30/2022 |
RAMELTEON ANDA #091693 |
SUPPL-3 |
RAMELTEON |
DR REDDYS LABS SA |
Labeling |
Approval |
06/30/2022 |
KYPROLIS NDA #202714 |
SUPPL-34 |
CARFILZOMIB |
ONYX PHARMS AMGEN |
Efficacy |
Approval |
06/30/2022 |
LENALIDOMIDE ANDA #209348 |
SUPPL-1 |
LENALIDOMIDE |
DR REDDYS |
REMS |
Approval |
06/30/2022 |
EMPAGLIFLOZIN ANDA #212421 |
ORIG-1 |
EMPAGLIFLOZIN |
LAURUS GENERICS INC |
|
Tentative Approval |
06/30/2022 |
DHIVY NDA #214869 |
SUPPL-2 |
CARBIDOPA; LEVODOPA |
AVION PHARMS |
Labeling |
Approval |