| 01/03/2022 |
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609 |
SUPPL-58 |
HEPARIN SODIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/03/2022 |
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609 |
SUPPL-58 |
HEPARIN SODIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/03/2022 |
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609 |
SUPPL-58 |
HEPARIN SODIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/03/2022 |
NOXAFIL
NDA #022003 |
SUPPL-30 |
POSACONAZOLE |
SCHERING |
Labeling |
Approval |
| 01/03/2022 |
CEFEPIME HYDROCHLORIDE
ANDA #065441 |
SUPPL-26 |
CEFEPIME HYDROCHLORIDE |
ACS DOBFAR |
Labeling |
Approval |
| 01/03/2022 |
TRIAZOLAM
ANDA #074224 |
SUPPL-10 |
TRIAZOLAM |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
TRIAZOLAM
ANDA #074224 |
SUPPL-11 |
TRIAZOLAM |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
SODIUM OXYBATE
ANDA #202090 |
SUPPL-1 |
SODIUM OXYBATE |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
SODIUM OXYBATE
ANDA #202090 |
SUPPL-2 |
SODIUM OXYBATE |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
SODIUM OXYBATE
ANDA #202090 |
SUPPL-3 |
SODIUM OXYBATE |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
SODIUM OXYBATE
ANDA #202090 |
SUPPL-4 |
SODIUM OXYBATE |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
SODIUM OXYBATE
ANDA #202090 |
SUPPL-5 |
SODIUM OXYBATE |
HIKMA |
Labeling |
Approval |
| 01/03/2022 |
DASATINIB
ANDA #202103 |
SUPPL-1 |
DASATINIB |
APOTEX |
Labeling |
Approval |
| 01/03/2022 |
DASATINIB
ANDA #202103 |
SUPPL-2 |
DASATINIB |
APOTEX |
Labeling |
Approval |
| 01/03/2022 |
DASATINIB
ANDA #202103 |
SUPPL-3 |
DASATINIB |
APOTEX |
Labeling |
Approval |
| 01/03/2022 |
DASATINIB
ANDA #202103 |
SUPPL-4 |
DASATINIB |
APOTEX |
Labeling |
Approval |
| 01/03/2022 |
DASATINIB
ANDA #202103 |
SUPPL-5 |
DASATINIB |
APOTEX |
Labeling |
Approval |
| 01/03/2022 |
DASATINIB
ANDA #202103 |
SUPPL-6 |
DASATINIB |
APOTEX |
Labeling |
Approval |
| 01/03/2022 |
BUPROPION HYDROCHLORIDE
ANDA #210015 |
SUPPL-15 |
BUPROPION HYDROCHLORIDE |
YICHANG HUMANWELL |
Labeling |
Approval |
| 01/03/2022 |
SPRAVATO
NDA #211243 |
SUPPL-6 |
ESKETAMINE HYDROCHLORIDE |
JANSSEN PHARMS |
REMS |
Approval |
| 01/03/2022 |
FENOFIBRIC ACID
ANDA #212562 |
SUPPL-1 |
CHOLINE FENOFIBRATE |
YICHANG HUMANWELL |
Labeling |
Approval |
| 01/03/2022 |
PIRFENIDONE
ANDA #212569 |
ORIG-1 |
PIRFENIDONE |
AMNEAL |
|
Approval |
| 01/03/2022 |
DOXYCYCLINE HYCLATE
ANDA #213075 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
ALEMBIC |
|
Approval |
| 01/03/2022 |
SILODOSIN
ANDA #213230 |
ORIG-1 |
SILODOSIN |
CREEKWOOD PHARMS |
|
Approval |
| 01/03/2022 |
THIOTEPA
ANDA #214222 |
SUPPL-1 |
THIOTEPA |
GLAND PHARMA LTD |
Manufacturing (CMC) |
Approval |
| 01/04/2022 |
FENOFIBRATE (MICRONIZED)
ANDA #202579 |
SUPPL-7 |
FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 01/04/2022 |
FENOFIBRATE
ANDA #204475 |
SUPPL-2 |
FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 01/04/2022 |
FENOFIBRATE
ANDA #204475 |
SUPPL-3 |
FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 01/04/2022 |
FENOFIBRATE
ANDA #204475 |
SUPPL-5 |
FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 01/04/2022 |
SOLIFENACIN SUCCINATE
ANDA #207477 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
ACCORD HLTHCARE |
|
Approval |
| 01/04/2022 |
SILODOSIN
ANDA #209029 |
ORIG-1 |
SILODOSIN |
PRINSTON INC |
|
Approval |
| 01/04/2022 |
METOPROLOL SUCCINATE
ANDA #210597 |
ORIG-1 |
METOPROLOL SUCCINATE |
PRINSTON INC |
|
Approval |
| 01/04/2022 |
ENTACAPONE
ANDA #212601 |
ORIG-1 |
ENTACAPONE |
ALEMBIC |
|
Approval |
| 01/04/2022 |
DIHYDROERGOTAMINE MESYLATE
ANDA #214105 |
ORIG-1 |
DIHYDROERGOTAMINE MESYLATE |
AMNEAL |
|
Approval |
| 01/04/2022 |
VENLAFAXINE HYDROCHLORIDE
ANDA #214423 |
ORIG-1 |
VENLAFAXINE HYDROCHLORIDE |
SUNNY |
|
Approval |
| 01/05/2022 |
CELECOXIB
ANDA #200562 |
SUPPL-6 |
CELECOXIB |
WATSON LABS INC |
Labeling |
Approval |
| 01/05/2022 |
CELECOXIB
ANDA #202240 |
SUPPL-11 |
CELECOXIB |
LUPIN LTD |
Labeling |
Approval |
| 01/05/2022 |
BUPROPION HYDROCHLORIDE
ANDA #203650 |
SUPPL-1 |
BUPROPION HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 01/05/2022 |
NICOTINE POLACRILEX
ANDA #206393 |
SUPPL-13 |
NICOTINE POLACRILEX |
PERRIGO R AND D |
Manufacturing (CMC) |
Approval |
| 01/05/2022 |
CELECOXIB
ANDA #206827 |
SUPPL-9 |
CELECOXIB |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/05/2022 |
CELECOXIB
ANDA #208701 |
SUPPL-1 |
CELECOXIB |
CADILA PHARMS LTD |
Labeling |
Approval |
| 01/05/2022 |
BARHEMSYS
NDA #209510 |
SUPPL-4 |
AMISULPRIDE |
ACACIA |
Labeling |
Approval |
| 01/05/2022 |
MILNACIPRAN HYDROCHLORIDE
ANDA #210944 |
ORIG-1 |
MILNACIPRAN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
|
Tentative Approval |
| 01/05/2022 |
VORTIOXETINE
ANDA #211066 |
ORIG-1 |
VORTIOXETINE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 01/05/2022 |
CLOBAZAM
ANDA #213110 |
SUPPL-1 |
CLOBAZAM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/05/2022 |
OSELTAMIVIR PHOSPHATE
ANDA #213594 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
SUNSHINE |
|
Approval |
| 01/05/2022 |
PROGESTERONE
ANDA #215634 |
ORIG-1 |
PROGESTERONE |
XIROMED |
|
Approval |
| 01/05/2022 |
ABIRATERONE ACETATE
ANDA #215947 |
ORIG-1 |
ABIRATERONE ACETATE |
NOVUGEN |
|
Approval |
| 01/06/2022 |
STRATTERA
NDA #021411 |
SUPPL-50 |
ATOMOXETINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
| 01/06/2022 |
ZITHROMAX
NDA #050733 |
SUPPL-49 |
AZITHROMYCIN |
PFIZER |
Manufacturing (CMC) |
Approval |
| 01/06/2022 |
NICOTINE POLACRILEX
ANDA #206394 |
SUPPL-13 |
NICOTINE POLACRILEX |
PERRIGO R AND D |
Manufacturing (CMC) |
Approval |
| 01/06/2022 |
COLCHICINE
ANDA #215444 |
ORIG-1 |
COLCHICINE |
AUROBINDO PHARMA LTD |
|
Approval |
| 01/07/2022 |
NICARDIPINE HYDROCHLORIDE
NDA #022276 |
SUPPL-20 |
NICARDIPINE HYDROCHLORIDE |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 01/07/2022 |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA #022276 |
SUPPL-20 |
NICARDIPINE HYDROCHLORIDE |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 01/07/2022 |
FAMOTIDINE
ANDA #075684 |
SUPPL-13 |
FAMOTIDINE |
SAGENT |
Labeling |
Approval |
| 01/07/2022 |
METOPROLOL TARTRATE
ANDA #077761 |
SUPPL-24 |
METOPROLOL TARTRATE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 01/07/2022 |
MELOXICAM
ANDA #077928 |
SUPPL-6 |
MELOXICAM |
STRIDES PHARMA |
Labeling |
Approval |
| 01/07/2022 |
MELOXICAM
ANDA #077929 |
SUPPL-13 |
MELOXICAM |
CIPLA |
Labeling |
Approval |
| 01/07/2022 |
MELOXICAM
ANDA #077932 |
SUPPL-10 |
MELOXICAM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/07/2022 |
MELOXICAM
ANDA #077944 |
SUPPL-19 |
MELOXICAM |
LUPIN PHARMS |
Labeling |
Approval |
| 01/07/2022 |
MELOXICAM
ANDA #078008 |
SUPPL-21 |
MELOXICAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/07/2022 |
TOPIRAMATE
ANDA #078235 |
SUPPL-31 |
TOPIRAMATE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 01/07/2022 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-8 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 01/07/2022 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-9 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 01/07/2022 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-10 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 01/07/2022 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-11 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 01/07/2022 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-12 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 01/07/2022 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-13 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 01/07/2022 |
TOPIRAMATE
ANDA #078877 |
SUPPL-21 |
TOPIRAMATE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 01/07/2022 |
PANTOPRAZOLE SODIUM
ANDA #090074 |
SUPPL-24 |
PANTOPRAZOLE SODIUM |
TORRENT PHARMS |
Labeling |
Approval |
| 01/07/2022 |
DRONEDARONE
ANDA #205933 |
ORIG-1 |
DRONEDARONE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 01/07/2022 |
GENVOYA
NDA #207561 |
SUPPL-29 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 01/07/2022 |
DESCOVY
NDA #208215 |
SUPPL-20 |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 01/07/2022 |
SEVELAMER CARBONATE
ANDA #209374 |
SUPPL-1 |
SEVELAMER CARBONATE |
BIONPHARMA |
Manufacturing (CMC) |
Approval |
| 01/07/2022 |
QUVIVIQ
NDA #214985 |
ORIG-1 |
DARIDOREXANT HYDROCHLORIDE |
IDORSIA |
Type 1 - New Molecular Entity |
Approval |
| 01/07/2022 |
FAMOTIDINE
ANDA #215630 |
ORIG-1 |
FAMOTIDINE |
ALKEM LABS LTD |
|
Approval |
| 01/07/2022 |
ULTOMIRIS
BLA #761108 |
SUPPL-20 |
RAVULIZUMAB-CWVZ |
ALEXION PHARM |
|
Approval |
| 01/10/2022 |
ADVIL PM
NDA #021394 |
SUPPL-32 |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-15 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-16 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-17 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-18 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-20 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-21 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-22 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-23 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-25 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-27 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
TOPIRAMATE
ANDA #078462 |
SUPPL-28 |
TOPIRAMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/10/2022 |
KYLEENA
NDA #208224 |
SUPPL-4 |
LEVONORGESTREL |
BAYER HLTHCARE |
Labeling |
Approval |
| 01/10/2022 |
SCOPOLAMINE
ANDA #208769 |
ORIG-1 |
SCOPOLAMINE |
ACTAVIS LABS UT INC |
|
Approval |
| 01/10/2022 |
ADVIL DUAL ACTION WITH ACETAMINOPHEN
NDA #211733 |
SUPPL-3 |
ACETAMINOPHEN; IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/11/2022 |
ADVIL PM
NDA #021393 |
SUPPL-21 |
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/11/2022 |
BONIVA
NDA #021858 |
SUPPL-23 |
IBANDRONATE SODIUM |
ROCHE |
Labeling |
Approval |
| 01/11/2022 |
AZASAN
ANDA #075252 |
SUPPL-21 |
AZATHIOPRINE |
AAIPHARMA LLC |
Labeling |
Approval |
| 01/11/2022 |
XIAFLEX
BLA #125338 |
SUPPL-121 |
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM |
AUXILIUM PHARMS |
|
Approval |
| 01/11/2022 |
DOCETAXEL
ANDA #204193 |
SUPPL-11 |
DOCETAXEL |
DR REDDYS |
Labeling |
Approval |
| 01/11/2022 |
CELECOXIB
ANDA #210628 |
SUPPL-2 |
CELECOXIB |
UMEDICA |
Labeling |
Approval |
| 01/11/2022 |
OXCARBAZEPINE
ANDA #215939 |
ORIG-1 |
OXCARBAZEPINE |
ANNORA PHARMA |
|
Approval |
| 01/12/2022 |
TOPROL-XL
NDA #019962 |
SUPPL-48 |
METOPROLOL SUCCINATE |
TOPROL |
Labeling |
Approval |
| 01/12/2022 |
HEPARIN SODIUM
ANDA #090809 |
SUPPL-8 |
HEPARIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 01/12/2022 |
HEPARIN SODIUM
ANDA #090809 |
SUPPL-10 |
HEPARIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 01/12/2022 |
HEPARIN SODIUM PRESERVATIVE FREE
ANDA #090810 |
SUPPL-10 |
HEPARIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 01/12/2022 |
HEPARIN SODIUM PRESERVATIVE FREE
ANDA #090810 |
SUPPL-11 |
HEPARIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 01/12/2022 |
SKYLA
NDA #203159 |
SUPPL-13 |
LEVONORGESTREL |
BAYER HLTHCARE |
Labeling |
Approval |
| 01/12/2022 |
MORPHINE SULFATE
ANDA #207270 |
ORIG-1 |
MORPHINE SULFATE |
DR REDDYS LABS SA |
|
Approval |
| 01/12/2022 |
AZITHROMYCIN
ANDA #207370 |
SUPPL-9 |
AZITHROMYCIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/12/2022 |
AZITHROMYCIN
ANDA #207398 |
SUPPL-9 |
AZITHROMYCIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/12/2022 |
AZITHROMYCIN
ANDA #209201 |
SUPPL-4 |
AZITHROMYCIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/12/2022 |
VORTIOXETINE
ANDA #211084 |
ORIG-1 |
VORTIOXETINE |
SIGMAPHARM LABS LLC |
|
Tentative Approval |
| 01/12/2022 |
XOSPATA
NDA #211349 |
SUPPL-3 |
GILTERITINIB FUMARATE |
ASTELLAS |
Labeling |
Approval |
| 01/12/2022 |
AZITHROMYCIN
ANDA #211793 |
SUPPL-9 |
AZITHROMYCIN |
ALEMBIC |
Labeling |
Approval |
| 01/13/2022 |
DROXIA
NDA #016295 |
SUPPL-56 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 01/13/2022 |
HYDREA
NDA #016295 |
SUPPL-56 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 01/13/2022 |
TOPAMAX
NDA #020505 |
SUPPL-62 |
TOPIRAMATE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/13/2022 |
TOPAMAX
NDA #020844 |
SUPPL-53 |
TOPIRAMATE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/13/2022 |
TOPAMAX SPRINKLE
NDA #020844 |
SUPPL-53 |
TOPIRAMATE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/13/2022 |
NOXAFIL
NDA #022003 |
SUPPL-28 |
POSACONAZOLE |
SCHERING |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796 |
SUPPL-30 |
CEFTRIAXONE SODIUM |
B BRAUN |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065125 |
SUPPL-30 |
CEFTRIAXONE SODIUM |
LUPIN |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065168 |
SUPPL-32 |
CEFTRIAXONE SODIUM |
SANDOZ |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065169 |
SUPPL-35 |
CEFTRIAXONE SODIUM |
SANDOZ |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065180 |
SUPPL-11 |
CEFTRIAXONE SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065204 |
SUPPL-28 |
CEFTRIAXONE SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE IN PLASTIC CONTAINER
ANDA #065224 |
SUPPL-13 |
CEFTRIAXONE SODIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065305 |
SUPPL-6 |
CEFTRIAXONE SODIUM |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065328 |
SUPPL-16 |
CEFTRIAXONE SODIUM |
ACS DOBFAR |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065329 |
SUPPL-19 |
CEFTRIAXONE SODIUM |
ACS DOBFAR |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065342 |
SUPPL-22 |
CEFTRIAXONE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #065391 |
SUPPL-12 |
CEFTRIAXONE SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #090057 |
SUPPL-4 |
CEFTRIAXONE SODIUM |
SAMSON MEDCL |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE SODIUM
ANDA #090701 |
SUPPL-4 |
CEFTRIAXONE SODIUM |
HIKMA |
Labeling |
Approval |
| 01/13/2022 |
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
ANDA #090747 |
SUPPL-18 |
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE |
AM REGENT |
Manufacturing (CMC) |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #091049 |
SUPPL-6 |
CEFTRIAXONE SODIUM |
ASTRAL |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE SODIUM
ANDA #091117 |
SUPPL-5 |
CEFTRIAXONE SODIUM |
ANDA REPOSITORY |
Labeling |
Approval |
| 01/13/2022 |
CAMPATH
BLA #103948 |
SUPPL-5184 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 01/13/2022 |
LEMTRADA
BLA #103948 |
SUPPL-5184 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 01/13/2022 |
XTANDI
NDA #203415 |
SUPPL-18 |
ENZALUTAMIDE |
ASTELLAS |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #203702 |
SUPPL-8 |
CEFTRIAXONE SODIUM |
QILU |
Labeling |
Approval |
| 01/13/2022 |
NOXAFIL
NDA #205053 |
SUPPL-14 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/13/2022 |
OXALIPLATIN
ANDA #205529 |
SUPPL-3 |
OXALIPLATIN |
EUGIA PHARMA |
Labeling |
Approval |
| 01/13/2022 |
NOXAFIL
NDA #205596 |
SUPPL-15 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/13/2022 |
OFEV
NDA #205832 |
SUPPL-16 |
NINTEDANIB ESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/13/2022 |
LURASIDONE HYDROCHLORIDE
ANDA #208049 |
SUPPL-1 |
LURASIDONE HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 01/13/2022 |
CEFTRIAXONE
ANDA #209218 |
SUPPL-4 |
CEFTRIAXONE SODIUM |
QILU |
Labeling |
Approval |
| 01/13/2022 |
RYALTRIS
NDA #211746 |
ORIG-1 |
MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE |
GLENMARK SPECIALTY |
Type 4 - New Combination |
Approval |
| 01/13/2022 |
AZITHROMYCIN
ANDA #211791 |
SUPPL-9 |
AZITHROMYCIN |
ALEMBIC |
Labeling |
Approval |
| 01/13/2022 |
AZITHROMYCIN
ANDA #211792 |
SUPPL-9 |
AZITHROMYCIN |
ALEMBIC |
Labeling |
Approval |
| 01/13/2022 |
OSELTAMIVIR PHOSPHATE
ANDA #211894 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
STRIDES PHARMA |
|
Approval |
| 01/13/2022 |
AMZEEQ
NDA #212379 |
SUPPL-7 |
MINOCYCLINE HYDROCHLORIDE |
JOURNEY |
Manufacturing (CMC) |
Approval |
| 01/13/2022 |
XTANDI
NDA #213674 |
SUPPL-5 |
ENZALUTAMIDE |
ASTELLAS |
Labeling |
Approval |
| 01/13/2022 |
ESOMEPRAZOLE MAGNESIUM
ANDA #213859 |
SUPPL-1 |
ESOMEPRAZOLE MAGNESIUM |
GUANGZHOU NOVAKEN |
Labeling |
Approval |
| 01/13/2022 |
POTASSIUM CHLORIDE
ANDA #214656 |
ORIG-1 |
POTASSIUM CHLORIDE |
RUBICON |
|
Approval |
| 01/13/2022 |
NOXAFIL POWDERMIX KIT
NDA #214770 |
SUPPL-2 |
POSACONAZOLE |
MSD MERCK CO |
Labeling |
Approval |
| 01/14/2022 |
DUTOPROL
NDA #021956 |
SUPPL-11 |
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE |
CONCORDIA |
Labeling |
Approval |
| 01/14/2022 |
RIFAMPIN
ANDA #064150 |
SUPPL-36 |
RIFAMPIN |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/14/2022 |
VALPROIC ACID
ANDA #073484 |
SUPPL-39 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 01/14/2022 |
VALPROIC ACID
ANDA #073484 |
SUPPL-42 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 01/14/2022 |
DEXAMETHASONE
ANDA #088481 |
SUPPL-27 |
DEXAMETHASONE |
ALVOGEN |
Manufacturing (CMC) |
Approval |
| 01/14/2022 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617 |
SUPPL-29 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 01/14/2022 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203010 |
SUPPL-19 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
ALEMBIC |
Labeling |
Approval |
| 01/14/2022 |
CAPECITABINE
ANDA #204345 |
SUPPL-1 |
CAPECITABINE |
DR REDDYS |
Labeling |
Approval |
| 01/14/2022 |
ORBACTIV
NDA #206334 |
SUPPL-7 |
ORITAVANCIN DIPHOSPHATE |
MELINTA THERAP |
Labeling |
Approval |
| 01/14/2022 |
RINVOQ
NDA #211675 |
SUPPL-4 |
UPADACITINIB |
ABBVIE |
Efficacy |
Approval |
| 01/14/2022 |
DEFERIPRONE
ANDA #213239 |
SUPPL-4 |
DEFERIPRONE |
HIKMA |
Labeling |
Approval |
| 01/14/2022 |
CIBINQO
NDA #213871 |
ORIG-1 |
ABROCITINIB |
PFIZER |
Type 1 - New Molecular Entity |
Approval |
| 01/14/2022 |
REGADENOSON
ANDA #214440 |
ORIG-1 |
REGADENOSON |
GLENMARK PHARMS LTD |
|
Tentative Approval |
| 01/14/2022 |
SOVUNA
NDA #214581 |
ORIG-1 |
HYDROXYCHLOROQUINE SULFATE |
NOVITIUM PHARMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/14/2022 |
ADAPALENE
ANDA #215940 |
ORIG-1 |
ADAPALENE |
TARO |
|
Approval |
| 01/18/2022 |
LAMOTRIGINE
ANDA #078409 |
SUPPL-8 |
LAMOTRIGINE |
SANDOZ |
Labeling |
Approval |
| 01/18/2022 |
LAMOTRIGINE
ANDA #078409 |
SUPPL-9 |
LAMOTRIGINE |
SANDOZ |
Labeling |
Approval |
| 01/18/2022 |
LAMOTRIGINE
ANDA #078409 |
SUPPL-10 |
LAMOTRIGINE |
SANDOZ |
Labeling |
Approval |
| 01/18/2022 |
LAMOTRIGINE
ANDA #078645 |
SUPPL-10 |
LAMOTRIGINE |
SANDOZ |
Labeling |
Approval |
| 01/18/2022 |
LAMOTRIGINE
ANDA #078645 |
SUPPL-11 |
LAMOTRIGINE |
SANDOZ |
Labeling |
Approval |
| 01/18/2022 |
LAMOTRIGINE
ANDA #078645 |
SUPPL-12 |
LAMOTRIGINE |
SANDOZ |
Labeling |
Approval |
| 01/18/2022 |
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473 |
SUPPL-5 |
LINEZOLID |
HOSPIRA |
Labeling |
Approval |
| 01/18/2022 |
EXONDYS 51
NDA #206488 |
SUPPL-27 |
ETEPLIRSEN |
SAREPTA THERAPS INC |
Labeling |
Approval |
| 01/18/2022 |
EXONDYS 51
NDA #206488 |
SUPPL-28 |
ETEPLIRSEN |
SAREPTA THERAPS INC |
Labeling |
Approval |
| 01/18/2022 |
EXONDYS 51
NDA #206488 |
SUPPL-29 |
ETEPLIRSEN |
SAREPTA THERAPS INC |
Labeling |
Approval |
| 01/18/2022 |
LUBIPROSTONE
ANDA #209920 |
ORIG-1 |
LUBIPROSTONE |
TEVA PHARMS USA INC |
|
Approval |
| 01/18/2022 |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
ANDA #209941 |
ORIG-1 |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
LANNETT CO INC |
|
Tentative Approval |
| 01/18/2022 |
LIVTENCITY
NDA #215596 |
SUPPL-1 |
MARIBAVIR |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 01/18/2022 |
CLINDAMYCIN PHOSPHATE
ANDA #215607 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
ENCUBE |
|
Approval |
| 01/19/2022 |
ALINIA
NDA #021497 |
SUPPL-18 |
NITAZOXANIDE |
ROMARK |
Labeling |
Approval |
| 01/19/2022 |
ALINIA
NDA #021498 |
SUPPL-19 |
NITAZOXANIDE |
ROMARK |
Labeling |
Approval |
| 01/19/2022 |
RIFAMPIN
ANDA #065390 |
SUPPL-20 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/19/2022 |
PAROXETINE HYDROCHLORIDE
ANDA #078406 |
SUPPL-31 |
PAROXETINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/19/2022 |
PAROXETINE HYDROCHLORIDE
ANDA #078406 |
SUPPL-32 |
PAROXETINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/19/2022 |
MONTELUKAST SODIUM
ANDA #091414 |
SUPPL-17 |
MONTELUKAST SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 01/19/2022 |
MONTELUKAST SODIUM
ANDA #200889 |
SUPPL-14 |
MONTELUKAST SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 01/19/2022 |
MONTELUKAST SODIUM
ANDA #202096 |
SUPPL-25 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/19/2022 |
MONTELUKAST SODIUM
ANDA #202468 |
SUPPL-27 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/19/2022 |
ASPIRIN AND DIPYRIDAMOLE
ANDA #206739 |
SUPPL-4 |
ASPIRIN; DIPYRIDAMOLE |
SANDOZ |
Labeling |
Approval |
| 01/19/2022 |
TAGRISSO
NDA #208065 |
SUPPL-25 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Labeling |
Approval |
| 01/19/2022 |
POTASSIUM CHLORIDE
ANDA #209786 |
SUPPL-3 |
POTASSIUM CHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 01/19/2022 |
TRIAMCINOLONE ACETONIDE
ANDA #213543 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
LONG GROVE PHARMS |
|
Approval |
| 01/19/2022 |
RANOLAZINE
ANDA #214035 |
ORIG-1 |
RANOLAZINE |
VKT PHARMA |
|
Approval |
| 01/19/2022 |
VEKLURY
NDA #214787 |
SUPPL-9 |
REMDESIVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 01/19/2022 |
OFLOXACIN
ANDA #215038 |
ORIG-1 |
OFLOXACIN |
FDC LTD |
|
Approval |
| 01/19/2022 |
VIGABATRIN
ANDA #215707 |
ORIG-1 |
VIGABATRIN |
ZYDUS LIFESCIENCES |
|
Approval |
| 01/20/2022 |
NOXAFIL
NDA #022003 |
SUPPL-27 |
POSACONAZOLE |
SCHERING |
Labeling |
Approval |
| 01/20/2022 |
NOXAFIL
NDA #205053 |
SUPPL-13 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/20/2022 |
NOXAFIL
NDA #205596 |
SUPPL-14 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/20/2022 |
DOVATO
NDA #211994 |
SUPPL-12 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 01/20/2022 |
DOVATO
NDA #211994 |
SUPPL-13 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 01/20/2022 |
EMPAGLIFLOZIN AND LINAGLIPTIN
ANDA #212264 |
ORIG-1 |
EMPAGLIFLOZIN; LINAGLIPTIN |
PRINSTON PHARMA INC |
|
Tentative Approval |
| 01/20/2022 |
PIRFENIDONE
ANDA #212731 |
ORIG-1 |
PIRFENIDONE |
ACCORD HLTHCARE |
|
Approval |
| 01/20/2022 |
NOXAFIL POWDERMIX KIT
NDA #214770 |
SUPPL-1 |
POSACONAZOLE |
MSD MERCK CO |
Labeling |
Approval |
| 01/21/2022 |
IXEMPRA KIT
NDA #022065 |
SUPPL-11 |
IXABEPILONE |
R-PHARM US LLC |
Labeling |
Approval |
| 01/21/2022 |
PANTOPRAZOLE SODIUM
ANDA #077619 |
SUPPL-17 |
PANTOPRAZOLE SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/21/2022 |
PANTOPRAZOLE SODIUM
ANDA #078281 |
SUPPL-29 |
PANTOPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 01/21/2022 |
PANTOPRAZOLE SODIUM
ANDA #078281 |
SUPPL-30 |
PANTOPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 01/21/2022 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #203129 |
SUPPL-7 |
DEXAMETHASONE SODIUM PHOSPHATE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 01/21/2022 |
TRI-LO-MILI
ANDA #205762 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/21/2022 |
DABIGATRAN ETEXILATE MESYLATE
ANDA #208067 |
ORIG-1 |
DABIGATRAN ETEXILATE MESYLATE |
MYLAN PHARMS INC |
|
Tentative Approval |
| 01/21/2022 |
BUSULFAN
ANDA #209580 |
SUPPL-5 |
BUSULFAN |
AMNEAL |
Labeling |
Approval |
| 01/21/2022 |
COLESEVELAM HYDROCHLORIDE
ANDA #213456 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
UNITED RES LABS |
|
Approval |
| 01/21/2022 |
TABRECTA
NDA #213591 |
SUPPL-2 |
CAPMATINIB HYDROCHLORIDE |
NOVARTIS PHARM |
Labeling |
Approval |
| 01/21/2022 |
METHYLPREDNISOLONE ACETATE
ANDA #214297 |
ORIG-1 |
METHYLPREDNISOLONE ACETATE |
ENDO OPERATIONS |
|
Approval |
| 01/21/2022 |
VEKLURY
NDA #214787 |
SUPPL-10 |
REMDESIVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 01/21/2022 |
CHOLESTYRAMINE
ANDA #214877 |
ORIG-1 |
CHOLESTYRAMINE |
UPSHER SMITH LABS |
|
Approval |
| 01/21/2022 |
TECENTRIQ
BLA #761034 |
SUPPL-43 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 01/21/2022 |
DARZALEX
BLA #761036 |
SUPPL-40 |
DARATUMUMAB |
JANSSEN BIOTECH |
|
Approval |
| 01/21/2022 |
SKYRIZI
BLA #761105 |
SUPPL-14 |
RISANKIZUMAB-RZAA |
ABBVIE INC |
|
Approval |
| 01/21/2022 |
DARZALEX FASPRO
BLA #761145 |
SUPPL-12 |
DARATUMUMAB;HYALURONIDASE-FIHJ |
JANSSEN BIOTECH |
|
Approval |
| 01/22/2022 |
NUCALA
BLA #125526 |
SUPPL-19 |
MEPOLIZUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
| 01/22/2022 |
NUCALA
BLA #761122 |
SUPPL-8 |
MEPOLIZUMAB |
GLAXOSMITHKLINE |
|
Approval |
| 01/24/2022 |
MERCAPTOPURINE
ANDA #040594 |
SUPPL-13 |
MERCAPTOPURINE |
MYLAN |
Labeling |
Approval |
| 01/24/2022 |
MONTELUKAST SODIUM
ANDA #090655 |
SUPPL-8 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/24/2022 |
MONTELUKAST SODIUM
ANDA #091128 |
SUPPL-8 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/24/2022 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202544 |
SUPPL-2 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/24/2022 |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #203053 |
ORIG-1 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
HETERO LABS LTD V |
|
Approval |
| 01/24/2022 |
TIGECYCLINE
ANDA #206335 |
SUPPL-1 |
TIGECYCLINE |
EUGIA PHARMA |
Labeling |
Approval |
| 01/24/2022 |
TIGECYCLINE
ANDA #206335 |
SUPPL-2 |
TIGECYCLINE |
EUGIA PHARMA |
Labeling |
Approval |
| 01/24/2022 |
LANTHANUM CARBONATE
ANDA #206868 |
ORIG-1 |
LANTHANUM CARBONATE |
INVAGEN PHARMS |
|
Approval |
| 01/24/2022 |
RUKOBIA
NDA #212950 |
SUPPL-2 |
FOSTEMSAVIR TROMETHAMINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 01/24/2022 |
DOXERCALCIFEROL
ANDA #213717 |
ORIG-1 |
DOXERCALCIFEROL |
EUGIA PHARMA |
|
Approval |
| 01/25/2022 |
ADVIL LIQUI-GELS
NDA #020402 |
SUPPL-53 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/25/2022 |
ADVIL MIGRAINE LIQUI-GELS
NDA #020402 |
SUPPL-53 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/25/2022 |
OMNITROPE
BLA #021426 |
SUPPL-50 |
SOMATROPIN |
SANDOZ |
|
Approval |
| 01/25/2022 |
DULOXETINE HYDROCHLORIDE
ANDA #090778 |
SUPPL-26 |
DULOXETINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/25/2022 |
TRI-MILI
ANDA #205441 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/25/2022 |
MILI
ANDA #205449 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/25/2022 |
CHLORTHALIDONE
ANDA #209068 |
ORIG-1 |
CHLORTHALIDONE |
SUNNY |
|
Approval |
| 01/25/2022 |
EPINEPHRINE
NDA #209359 |
SUPPL-7 |
EPINEPHRINE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 01/25/2022 |
MYCOPHENOLATE MOFETIL
ANDA #211272 |
ORIG-1 |
MYCOPHENOLATE MOFETIL |
TEVA PHARMS USA |
|
Approval |
| 01/25/2022 |
REYVOW
NDA #211280 |
SUPPL-6 |
LASMIDITAN SUCCINATE |
ELI LILLY AND CO |
Manufacturing (CMC) |
Approval |
| 01/25/2022 |
ADVIL DUAL ACTION WITH ACETAMINOPHEN
NDA #211733 |
SUPPL-4 |
ACETAMINOPHEN; IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/25/2022 |
PIRFENIDONE
ANDA #212730 |
ORIG-1 |
PIRFENIDONE |
ACCORD HLTHCARE |
|
Approval |
| 01/25/2022 |
PIRFENIDONE
ANDA #212759 |
ORIG-1 |
PIRFENIDONE |
TEVA PHARMS USA |
|
Approval |
| 01/25/2022 |
CARBIDOPA, LEVODOPA AND ENTACAPONE
ANDA #213212 |
ORIG-1 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
RISING |
|
Approval |
| 01/25/2022 |
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
NDA #213645 |
ORIG-1 |
DAPTOMYCIN |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/25/2022 |
DAPZURA RT
NDA #213645 |
ORIG-1 |
DAPTOMYCIN |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/25/2022 |
BACLOFEN
ANDA #215885 |
ORIG-1 |
BACLOFEN |
MANKIND PHARMA |
|
Approval |
| 01/25/2022 |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #215936 |
ORIG-1 |
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
MICRO LABS |
|
Approval |
| 01/25/2022 |
KIMMTRAK
BLA #761228 |
ORIG-1 |
TEBENTAFUSP-TEBN |
IMMUNOCORE LTD |
|
Approval |
| 01/26/2022 |
ISOSORBIDE MONONITRATE
ANDA #075522 |
SUPPL-22 |
ISOSORBIDE MONONITRATE |
DEXCEL LTD |
Labeling |
Approval |
| 01/26/2022 |
IRBESARTAN
ANDA #090720 |
SUPPL-3 |
IRBESARTAN |
WATSON LABS INC |
Labeling |
Approval |
| 01/26/2022 |
SOLIFENACIN SUCCINATE
ANDA #091464 |
SUPPL-3 |
SOLIFENACIN SUCCINATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 01/26/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200494 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/26/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200494 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/26/2022 |
NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #200494 |
SUPPL-7 |
NORGESTIMATE; ETHINYL ESTRADIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/26/2022 |
NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #200494 |
SUPPL-9 |
NORGESTIMATE; ETHINYL ESTRADIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/26/2022 |
TEMOZOLOMIDE
ANDA #203691 |
SUPPL-8 |
TEMOZOLOMIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 01/26/2022 |
NEBIVOLOL HYDROCHLORIDE
ANDA #203821 |
SUPPL-1 |
NEBIVOLOL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/26/2022 |
TEMOZOLOMIDE
ANDA #204639 |
SUPPL-2 |
TEMOZOLOMIDE |
CHEMI SPA |
Labeling |
Approval |
| 01/26/2022 |
ATHENTIA NEXT
ANDA #206867 |
SUPPL-4 |
LEVONORGESTREL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/26/2022 |
NEXESTA FE
ANDA #207535 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/26/2022 |
SOLOSEC
NDA #209363 |
SUPPL-14 |
SECNIDAZOLE |
LUPIN |
Efficacy |
Approval |
| 01/26/2022 |
SOLOSEC
NDA #209363 |
SUPPL-16 |
SECNIDAZOLE |
LUPIN |
Efficacy |
Approval |
| 01/26/2022 |
POMALIDOMIDE
ANDA #210275 |
ORIG-1 |
POMALIDOMIDE |
MYLAN |
|
Approval |
| 01/26/2022 |
SOLIFENACIN SUCCINATE
ANDA #210688 |
SUPPL-5 |
SOLIFENACIN SUCCINATE |
MSN |
Labeling |
Approval |
| 01/26/2022 |
FOSFOMYCIN TROMETHAMINE
ANDA #211881 |
ORIG-1 |
FOSFOMYCIN TROMETHAMINE |
CIPLA |
|
Approval |
| 01/26/2022 |
ALLOPURINOL SODIUM
ANDA #212363 |
ORIG-1 |
ALLOPURINOL SODIUM |
GLAND PHARMA LTD |
|
Approval |
| 01/26/2022 |
POTASSIUM CHLORIDE
ANDA #214076 |
ORIG-1 |
POTASSIUM CHLORIDE |
TRIS PHARMA INC |
|
Approval |
| 01/26/2022 |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #215138 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
HIKMA |
|
Approval |
| 01/26/2022 |
ATROPINE SULFATE
ANDA #215342 |
ORIG-1 |
ATROPINE SULFATE |
AMNEAL |
|
Approval |
| 01/26/2022 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #215995 |
ORIG-1 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
GLENMARK PHARMS LTD |
|
Approval |
| 01/27/2022 |
CAMPTOSAR
NDA #020571 |
SUPPL-52 |
IRINOTECAN HYDROCHLORIDE |
PFIZER INC |
Labeling |
Approval |
| 01/27/2022 |
CAMPTOSAR
NDA #020571 |
SUPPL-53 |
IRINOTECAN HYDROCHLORIDE |
PFIZER INC |
Labeling |
Approval |
| 01/27/2022 |
SEROQUEL
NDA #020639 |
SUPPL-72 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
| 01/27/2022 |
SEROQUEL XR
NDA #022047 |
SUPPL-46 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
| 01/27/2022 |
ADASUVE
NDA #022549 |
SUPPL-10 |
LOXAPINE |
ALEXZA PHARMS |
Labeling |
Approval |
| 01/27/2022 |
IDARUBICIN HYDROCHLORIDE
ANDA #065036 |
SUPPL-33 |
IDARUBICIN HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 01/27/2022 |
TRI-SPRINTEC
ANDA #075808 |
SUPPL-34 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR |
Labeling |
Approval |
| 01/27/2022 |
LETROZOLE
ANDA #090491 |
SUPPL-2 |
LETROZOLE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 01/27/2022 |
LANTHANUM CARBONATE
ANDA #090977 |
ORIG-1 |
LANTHANUM CARBONATE |
BARR |
|
Approval |
| 01/27/2022 |
NEBIVOLOL HYDROCHLORIDE
ANDA #203659 |
SUPPL-3 |
NEBIVOLOL HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 01/27/2022 |
TEMOZOLOMIDE
ANDA #203898 |
SUPPL-4 |
TEMOZOLOMIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/27/2022 |
TEMOZOLOMIDE
ANDA #203898 |
SUPPL-5 |
TEMOZOLOMIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/27/2022 |
PENNSAID
NDA #204623 |
SUPPL-9 |
DICLOFENAC SODIUM |
HORIZON |
Labeling |
Approval |
| 01/27/2022 |
PROAIR DIGIHALER
NDA #205636 |
SUPPL-23 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 01/27/2022 |
PROAIR RESPICLICK
NDA #205636 |
SUPPL-23 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 01/27/2022 |
MEMANTINE HYDROCHLORIDE
ANDA #205784 |
SUPPL-8 |
MEMANTINE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 01/27/2022 |
TEMOZOLOMIDE
ANDA #206309 |
SUPPL-1 |
TEMOZOLOMIDE |
RISING |
Labeling |
Approval |
| 01/27/2022 |
TEMOZOLOMIDE
ANDA #206309 |
SUPPL-2 |
TEMOZOLOMIDE |
RISING |
Labeling |
Approval |
| 01/27/2022 |
ARMONAIR DIGIHALER
NDA #208798 |
SUPPL-10 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Labeling |
Approval |
| 01/27/2022 |
ARMONAIR RESPICLICK
NDA #208798 |
SUPPL-10 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Labeling |
Approval |
| 01/27/2022 |
AIRDUO DIGIHALER
NDA #208799 |
SUPPL-19 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
| 01/27/2022 |
AIRDUO RESPICLICK
NDA #208799 |
SUPPL-19 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
| 01/27/2022 |
ERTAPENEM SODIUM
ANDA #209133 |
SUPPL-5 |
ERTAPENEM SODIUM |
EUGIA PHARMA |
Labeling |
Approval |
| 01/27/2022 |
PIFELTRO
NDA #210806 |
SUPPL-7 |
DORAVIRINE |
MSD MERCK CO |
Efficacy |
Approval |
| 01/27/2022 |
DELSTRIGO
NDA #210807 |
SUPPL-8 |
DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
MSD MERCK CO |
Efficacy |
Approval |
| 01/27/2022 |
SOFOSBUVIR
ANDA #211353 |
ORIG-1 |
SOFOSBUVIR |
TEVA PHARMS USA INC |
|
Approval |
| 01/27/2022 |
FUROSEMIDE
ANDA #212803 |
ORIG-1 |
FUROSEMIDE |
MEITHEAL |
|
Approval |
| 01/27/2022 |
LAMPIT
NDA #213464 |
SUPPL-3 |
NIFURTIMOX |
BAYER HEALTHCARE |
Labeling |
Approval |
| 01/27/2022 |
POTASSIUM CHLORIDE
ANDA #213467 |
ORIG-1 |
POTASSIUM CHLORIDE |
GRANULES |
|
Approval |
| 01/27/2022 |
CHLORPROMAZINE HYDROCHLORIDE
ANDA #214827 |
ORIG-1 |
CHLORPROMAZINE HYDROCHLORIDE |
MSN |
|
Approval |
| 01/27/2022 |
CARBOPROST TROMETHAMINE
ANDA #215337 |
ORIG-1 |
CARBOPROST TROMETHAMINE |
AMNEAL |
|
Approval |
| 01/27/2022 |
DORZOLAMIDE HYDROCHLORIDE
ANDA #215660 |
ORIG-1 |
DORZOLAMIDE HYDROCHLORIDE |
GLAND PHARMA LTD |
|
Approval |
| 01/27/2022 |
METRONIDAZOLE
ANDA #215794 |
ORIG-1 |
METRONIDAZOLE |
GLENMARK PHARMS LTD |
|
Approval |
| 01/27/2022 |
RENFLEXIS
BLA #761054 |
SUPPL-29 |
INFLIXIMAB-ABDA |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
| 01/28/2022 |
COPAXONE
NDA #020622 |
SUPPL-113 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 01/28/2022 |
GEODON
NDA #020825 |
SUPPL-63 |
ZIPRASIDONE HYDROCHLORIDE |
VIATRIS |
Efficacy |
Approval |
| 01/28/2022 |
VFEND
NDA #021266 |
SUPPL-52 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
| 01/28/2022 |
VFEND
NDA #021267 |
SUPPL-62 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
| 01/28/2022 |
VFEND
NDA #021630 |
SUPPL-41 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
| 01/28/2022 |
SPRINTEC
ANDA #075804 |
SUPPL-30 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR |
Labeling |
Approval |
| 01/28/2022 |
ENPRESSE-21
ANDA #075809 |
SUPPL-25 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 01/28/2022 |
ENPRESSE-21
ANDA #075809 |
SUPPL-27 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 01/28/2022 |
ENPRESSE-28
ANDA #075809 |
SUPPL-25 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 01/28/2022 |
ENPRESSE-28
ANDA #075809 |
SUPPL-27 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 01/28/2022 |
TRI LO SPRINTEC
ANDA #076784 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR LABS INC |
Labeling |
Approval |
| 01/28/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #078965 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 01/28/2022 |
BALANCED SALT
ANDA #091387 |
SUPPL-10 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE |
B BRAUN |
Manufacturing (CMC) |
Approval |
| 01/28/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200538 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/28/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200538 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/28/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202086 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
XIROMED |
Labeling |
Approval |
| 01/28/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202086 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
XIROMED |
Labeling |
Approval |
| 01/28/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 01/28/2022 |
TAFINLAR
NDA #202806 |
SUPPL-19 |
DABRAFENIB MESYLATE |
NOVARTIS |
Efficacy |
Approval |
| 01/28/2022 |
COLESEVELAM HYDROCHLORIDE
ANDA #203480 |
SUPPL-2 |
COLESEVELAM HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/28/2022 |
COLESEVELAM HYDROCHLORIDE
ANDA #203480 |
SUPPL-3 |
COLESEVELAM HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/28/2022 |
COLESEVELAM HYDROCHLORIDE
ANDA #203480 |
SUPPL-4 |
COLESEVELAM HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/28/2022 |
COLESEVELAM HYDROCHLORIDE
ANDA #203480 |
SUPPL-5 |
COLESEVELAM HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/28/2022 |
CEFEPIME HYDROCHLORIDE
ANDA #203704 |
SUPPL-14 |
CEFEPIME HYDROCHLORIDE |
QILU |
Labeling |
Approval |
| 01/28/2022 |
MEKINIST
NDA #204114 |
SUPPL-19 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Efficacy |
Approval |
| 01/28/2022 |
MEKINIST
NDA #204114 |
SUPPL-21 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Labeling |
Approval |
| 01/28/2022 |
AUROVELA 24 FE
ANDA #207504 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/28/2022 |
AUROVELA 24 FE
ANDA #207504 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/28/2022 |
TAFLUPROST
ANDA #209040 |
ORIG-1 |
TAFLUPROST |
SANDOZ |
|
Approval |
| 01/28/2022 |
YONSA
NDA #210308 |
SUPPL-2 |
ABIRATERONE ACETATE |
SUN PHARM |
Labeling |
Approval |
| 01/28/2022 |
CANAGLIFLOZIN
ANDA #210503 |
ORIG-1 |
CANAGLIFLOZIN |
LAURUS LABS LTD |
|
Tentative Approval |
| 01/28/2022 |
BETAINE
ANDA #210508 |
ORIG-1 |
BETAINE |
ETON |
|
Approval |
| 01/28/2022 |
SUTAB
NDA #213135 |
SUPPL-3 |
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE |
BRAINTREE LABS |
Labeling |
Approval |
| 01/28/2022 |
DOLUTEGRAVIR; LAMIVUDINE
ANDA #213579 |
ORIG-1 |
DOLUTEGRAVIR;LAMIVUDINE |
CIPLA USA |
|
Tentative Approval |
| 01/28/2022 |
FAMOTIDINE
ANDA #215822 |
ORIG-1 |
FAMOTIDINE |
VKT PHARMA |
|
Approval |
| 01/28/2022 |
VABYSMO
BLA #761235 |
ORIG-1 |
FARICIMAB-SVOA |
GENENTECH INC |
|
Approval |
| 01/29/2022 |
RIFADIN
NDA #050420 |
SUPPL-87 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/29/2022 |
RIFADIN
NDA #050627 |
SUPPL-30 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/29/2022 |
RIFATER
NDA #050705 |
SUPPL-21 |
ISONIAZID; PYRAZINAMIDE; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/30/2022 |
PRIMAXIN
NDA #050587 |
SUPPL-83 |
CILASTATIN SODIUM; IMIPENEM |
MERCK |
Labeling |
Approval |
| 01/31/2022 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065498 |
SUPPL-19 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 01/31/2022 |
IRBESARTAN
ANDA #077159 |
SUPPL-11 |
IRBESARTAN |
TEVA PHARMS |
Labeling |
Approval |
| 01/31/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077369 |
SUPPL-23 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TEVA |
Labeling |
Approval |
| 01/31/2022 |
BRIMONIDINE TARTRATE
ANDA #078479 |
ORIG-1 |
BRIMONIDINE TARTRATE |
APOTEX |
|
Approval |
| 01/31/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200384 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NAARI PTE LTD |
Labeling |
Approval |
| 01/31/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200384 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NAARI PTE LTD |
Labeling |
Approval |
| 01/31/2022 |
EDURANT
NDA #202022 |
SUPPL-16 |
RILPIVIRINE HYDROCHLORIDE |
JANSSEN PRODS |
Efficacy |
Approval |
| 01/31/2022 |
LYNPARZA
NDA #208558 |
SUPPL-21 |
OLAPARIB |
ASTRAZENECA |
Efficacy |
Approval |
| 01/31/2022 |
CLARITHROMYCIN
ANDA #210459 |
ORIG-1 |
CLARITHROMYCIN |
ALEMBIC |
|
Approval |
| 01/31/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #210876 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA PHARMS USA |
|
Approval |
| 01/31/2022 |
VOCABRIA
NDA #212887 |
SUPPL-1 |
CABOTEGRAVIR SODIUM |
VIIV HLTHCARE |
Efficacy |
Approval |
| 01/31/2022 |
CABENUVA KIT
NDA #212888 |
SUPPL-1 |
CABOTEGRAVIR; RILPIVIRINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 01/31/2022 |
CITALOPRAM HYDROBROMIDE
NDA #215428 |
ORIG-1 |
CITALOPRAM HYDROBROMIDE |
ALMATICA |
Type 2 - New Active Ingredient and Type 3 - New Dosage Form |
Approval |
