| 04/01/2020 |
ALOXI
NDA #021372 |
SUPPL-21 |
PALONOSETRON HYDROCHLORIDE |
HELSINN HLTHCARE |
Labeling |
Approval |
| 04/01/2020 |
ALOXI
NDA #022233 |
SUPPL-6 |
PALONOSETRON HYDROCHLORIDE |
HELSINN HLTHCARE |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040104 |
SUPPL-25 |
HYDROXYCHLOROQUINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040133 |
SUPPL-29 |
HYDROXYCHLOROQUINE SULFATE |
WATSON LABS |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040133 |
SUPPL-30 |
HYDROXYCHLOROQUINE SULFATE |
WATSON LABS |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040150 |
SUPPL-7 |
HYDROXYCHLOROQUINE SULFATE |
CREEKWOOD PHARMS |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040274 |
SUPPL-13 |
HYDROXYCHLOROQUINE SULFATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 04/01/2020 |
ETHOSUXIMIDE
ANDA #040430 |
SUPPL-13 |
ETHOSUXIMIDE |
BIONPHARMA |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040760 |
SUPPL-6 |
HYDROXYCHLOROQUINE SULFATE |
HIKMA PHARMS |
Labeling |
Approval |
| 04/01/2020 |
MONTELUKAST SODIUM
ANDA #078605 |
SUPPL-12 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
| 04/01/2020 |
MONTELUKAST SODIUM
ANDA #078723 |
SUPPL-12 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
| 04/01/2020 |
ESOMEPRAZOLE SODIUM
ANDA #203349 |
ORIG-1 |
ESOMEPRAZOLE SODIUM |
GLAND PHARMA LTD |
|
Approval |
| 04/01/2020 |
LAMOTRIGINE
ANDA #207763 |
ORIG-1 |
LAMOTRIGINE |
ZYDUS PHARMS |
|
Approval |
| 04/01/2020 |
AZITHROMYCIN
ANDA #209044 |
SUPPL-7 |
AZITHROMYCIN |
SUNSHINE |
Manufacturing (CMC) |
Approval |
| 04/01/2020 |
AZITHROMYCIN
ANDA #209045 |
SUPPL-7 |
AZITHROMYCIN |
SUNSHINE |
Manufacturing (CMC) |
Approval |
| 04/01/2020 |
ROSUVASTATIN CALCIUM
ANDA #210667 |
ORIG-1 |
ROSUVASTATIN CALCIUM |
SUNSHINE |
|
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #210959 |
SUPPL-1 |
HYDROXYCHLOROQUINE SULFATE |
LAURUS |
Labeling |
Approval |
| 04/01/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #210959 |
SUPPL-5 |
HYDROXYCHLOROQUINE SULFATE |
LAURUS |
Labeling |
Approval |
| 04/01/2020 |
DICLOFENAC SODIUM
ANDA #211253 |
SUPPL-5 |
DICLOFENAC SODIUM |
PERRIGO PHARMA INTL |
Labeling |
Approval |
| 04/02/2020 |
NEURONTIN
NDA #020235 |
SUPPL-68 |
GABAPENTIN |
VIATRIS |
Labeling |
Approval |
| 04/02/2020 |
NEURONTIN
NDA #020882 |
SUPPL-49 |
GABAPENTIN |
VIATRIS |
Labeling |
Approval |
| 04/02/2020 |
NEURONTIN
NDA #021129 |
SUPPL-49 |
GABAPENTIN |
VIATRIS |
Labeling |
Approval |
| 04/02/2020 |
MUCINEX
NDA #021282 |
SUPPL-51 |
GUAIFENESIN |
RB HLTH |
Manufacturing (CMC) |
Approval |
| 04/02/2020 |
NEXAVAR
NDA #021923 |
SUPPL-23 |
SORAFENIB TOSYLATE |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/02/2020 |
TRAVATAN Z
NDA #021994 |
SUPPL-13 |
TRAVOPROST |
SANDOZ |
Labeling |
Approval |
| 04/02/2020 |
HORIZANT
NDA #022399 |
SUPPL-11 |
GABAPENTIN ENACARBIL |
AZURITY |
Labeling |
Approval |
| 04/02/2020 |
GRALISE
NDA #022544 |
SUPPL-26 |
GABAPENTIN |
ALMATICA |
Labeling |
Approval |
| 04/02/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #079165 |
SUPPL-4 |
ROPINIROLE HYDROCHLORIDE |
MLV |
Labeling |
Approval |
| 04/02/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #079165 |
SUPPL-5 |
ROPINIROLE HYDROCHLORIDE |
MLV |
Labeling |
Approval |
| 04/02/2020 |
OMEGA-3-ACID ETHYL ESTERS
ANDA #091028 |
SUPPL-5 |
OMEGA-3-ACID ETHYL ESTERS |
GLW |
Labeling |
Approval |
| 04/02/2020 |
HEMANGEOL
NDA #205410 |
SUPPL-5 |
PROPRANOLOL HYDROCHLORIDE |
PIERRE FABRE DERMA |
Labeling |
Approval |
| 04/02/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207667 |
SUPPL-1 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
EUGIA PHARMA |
Labeling |
Approval |
| 04/02/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207667 |
SUPPL-2 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
EUGIA PHARMA |
Labeling |
Approval |
| 04/02/2020 |
CINACALCET HYDROCHLORIDE
ANDA #208915 |
SUPPL-2 |
CINACALCET HYDROCHLORIDE |
CIPLA |
Labeling |
Approval |
| 04/02/2020 |
BALVERSA
NDA #212018 |
SUPPL-1 |
ERDAFITINIB |
JANSSEN BIOTECH |
Labeling |
Approval |
| 04/02/2020 |
HEPARIN SODIUM PRESERVATIVE FREE
ANDA #212060 |
ORIG-1 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
|
Approval |
| 04/03/2020 |
REQUIP
NDA #020658 |
SUPPL-37 |
ROPINIROLE HYDROCHLORIDE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
| 04/03/2020 |
MIRAPEX
NDA #020667 |
SUPPL-41 |
PRAMIPEXOLE DIHYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 04/03/2020 |
CYCLOSET
NDA #020866 |
SUPPL-13 |
BROMOCRIPTINE MESYLATE |
VEROSCIENCE |
Labeling |
Approval |
| 04/03/2020 |
LYRICA
NDA #021446 |
SUPPL-40 |
PREGABALIN |
UPJOHN |
Labeling |
Approval |
| 04/03/2020 |
NEUPRO
NDA #021829 |
SUPPL-19 |
ROTIGOTINE |
UCB INC |
Labeling |
Approval |
| 04/03/2020 |
LYRICA
NDA #022488 |
SUPPL-17 |
PREGABALIN |
UPJOHN |
Labeling |
Approval |
| 04/03/2020 |
TOBRAMYCIN SULFATE
NDA #050789 |
SUPPL-6 |
TOBRAMYCIN SULFATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/03/2020 |
CLINDAMYCIN PHOSPHATE
ANDA #065049 |
SUPPL-16 |
CLINDAMYCIN PHOSPHATE |
PADAGIS US |
Labeling |
Approval |
| 04/03/2020 |
CLINDAMYCIN PHOSPHATE
ANDA #065049 |
SUPPL-23 |
CLINDAMYCIN PHOSPHATE |
PADAGIS US |
Labeling |
Approval |
| 04/03/2020 |
TIMOLOL MALEATE
ANDA #074746 |
SUPPL-16 |
TIMOLOL MALEATE |
PACIFIC PHARMA |
Labeling |
Approval |
| 04/03/2020 |
TIMOLOL MALEATE
ANDA #074747 |
SUPPL-17 |
TIMOLOL MALEATE |
PACIFIC PHARMA |
Labeling |
Approval |
| 04/03/2020 |
TIMOLOL MALEATE
ANDA #075163 |
SUPPL-4 |
TIMOLOL MALEATE |
HIKMA |
Labeling |
Approval |
| 04/03/2020 |
TIMOLOL MALEATE
ANDA #075411 |
SUPPL-28 |
TIMOLOL MALEATE |
APOTEX INC |
Labeling |
Approval |
| 04/03/2020 |
TIMOLOL MALEATE
ANDA #075412 |
SUPPL-30 |
TIMOLOL MALEATE |
APOTEX INC |
Labeling |
Approval |
| 04/03/2020 |
MOMETASONE FUROATE
ANDA #076591 |
SUPPL-14 |
MOMETASONE FUROATE |
ANDA REPOSITORY |
Labeling |
Approval |
| 04/03/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #079229 |
SUPPL-2 |
ROPINIROLE HYDROCHLORIDE |
ORBION PHARMS |
Labeling |
Approval |
| 04/03/2020 |
POLYETHYLENE GLYCOL 3350
ANDA #091077 |
SUPPL-8 |
POLYETHYLENE GLYCOL 3350 |
NOVEL LABS INC |
Labeling |
Approval |
| 04/03/2020 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091569 |
SUPPL-9 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/03/2020 |
NIKKI
ANDA #201661 |
SUPPL-10 |
DROSPIRENONE; ETHINYL ESTRADIOL |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 04/03/2020 |
DAPTOMYCIN
NDA #208385 |
SUPPL-5 |
DAPTOMYCIN |
SAGENT PHARMS INC |
Labeling |
Approval |
| 04/03/2020 |
LYRICA CR
NDA #209501 |
SUPPL-3 |
PREGABALIN |
UPJOHN |
Labeling |
Approval |
| 04/03/2020 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #210293 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
USPHARMA WINDLAS |
|
Approval |
| 04/03/2020 |
CLOMIPRAMINE HYDROCHLORIDE
ANDA #210653 |
ORIG-1 |
CLOMIPRAMINE HYDROCHLORIDE |
TULEX PHARMS INC |
|
Approval |
| 04/03/2020 |
MEMANTINE HYDROCHLORIDE
ANDA #212947 |
ORIG-1 |
MEMANTINE HYDROCHLORIDE |
YILING |
|
Approval |
| 04/03/2020 |
REBLOZYL
BLA #761136 |
ORIG-2 |
LUSPATERCEPT-AAMT |
CELGENE CORP |
|
Approval |
| 04/06/2020 |
ACTIVELLA
NDA #020907 |
SUPPL-25 |
ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL |
Manufacturing (CMC) |
Approval |
| 04/06/2020 |
ALEVE-D SINUS & COLD
NDA #021076 |
SUPPL-16 |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
BAYER |
Labeling |
Approval |
| 04/06/2020 |
FORTEO
NDA #021318 |
SUPPL-53 |
TERIPARATIDE |
LILLY |
Labeling |
Approval |
| 04/06/2020 |
ELOXATIN
NDA #021492 |
SUPPL-16 |
OXALIPLATIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 04/06/2020 |
ELOXATIN
NDA #021759 |
SUPPL-23 |
OXALIPLATIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 04/06/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #065156 |
SUPPL-15 |
MINOCYCLINE HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
| 04/06/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #065156 |
SUPPL-17 |
MINOCYCLINE HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
| 04/06/2020 |
BUMETANIDE
ANDA #074225 |
SUPPL-19 |
BUMETANIDE |
HERITAGE PHARMA |
Labeling |
Approval |
| 04/06/2020 |
BUMETANIDE
ANDA #074225 |
SUPPL-21 |
BUMETANIDE |
HERITAGE PHARMA |
Labeling |
Approval |
| 04/06/2020 |
BUMETANIDE
ANDA #074700 |
SUPPL-23 |
BUMETANIDE |
SANDOZ |
Labeling |
Approval |
| 04/06/2020 |
MOMETASONE FUROATE
ANDA #076679 |
SUPPL-16 |
MOMETASONE FUROATE |
TARO |
Labeling |
Approval |
| 04/06/2020 |
LEVOFLOXACIN
ANDA #076710 |
SUPPL-15 |
LEVOFLOXACIN |
DR REDDYS LABS INC |
Labeling |
Approval |
| 04/06/2020 |
LEVOFLOXACIN
ANDA #076890 |
SUPPL-16 |
LEVOFLOXACIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/06/2020 |
LEVOFLOXACIN
ANDA #076890 |
SUPPL-17 |
LEVOFLOXACIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/06/2020 |
LEVOFLOXACIN
ANDA #077438 |
SUPPL-19 |
LEVOFLOXACIN |
SANDOZ |
Labeling |
Approval |
| 04/06/2020 |
STELARA
BLA #125261 |
SUPPL-153 |
USTEKINUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
| 04/06/2020 |
MEGESTROL ACETATE
ANDA #203960 |
SUPPL-2 |
MEGESTROL ACETATE |
HIKMA |
Labeling |
Approval |
| 04/06/2020 |
IBUPROFEN
ANDA #204469 |
SUPPL-3 |
IBUPROFEN |
STRIDES PHARMA |
Manufacturing (CMC) |
Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #204603 |
SUPPL-2 |
OXYCODONE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #204603 |
SUPPL-6 |
OXYCODONE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #204603 |
SUPPL-7 |
OXYCODONE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 04/06/2020 |
PERPHENAZINE
ANDA #205232 |
ORIG-1 |
PERPHENAZINE |
ZYDUS PHARMS |
|
Approval |
| 04/06/2020 |
ALEVE PM
NDA #205352 |
SUPPL-14 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
BAYER HLTHCARE |
Labeling |
Approval |
| 04/06/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #205545 |
SUPPL-1 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 04/06/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #205545 |
SUPPL-4 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 04/06/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #205545 |
SUPPL-7 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 04/06/2020 |
CLINDAMYCIN PHOSPHATE
ANDA #206945 |
SUPPL-1 |
CLINDAMYCIN PHOSPHATE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
| 04/06/2020 |
CLINDAMYCIN PHOSPHATE
ANDA #206945 |
SUPPL-2 |
CLINDAMYCIN PHOSPHATE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
| 04/06/2020 |
CLINDAMYCIN PHOSPHATE
ANDA #206945 |
SUPPL-3 |
CLINDAMYCIN PHOSPHATE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
| 04/06/2020 |
TICAGRELOR
ANDA #208508 |
ORIG-1 |
TICAGRELOR |
SUNSHINE |
|
Approval |
| 04/06/2020 |
TICAGRELOR
ANDA #208508 |
ORIG-2 |
TICAGRELOR |
SUNSHINE |
|
Tentative Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #208795 |
SUPPL-2 |
OXYCODONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #208795 |
SUPPL-5 |
OXYCODONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/06/2020 |
SUCCINYLCHOLINE CHLORIDE
ANDA #209467 |
SUPPL-2 |
SUCCINYLCHOLINE CHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #209897 |
SUPPL-2 |
OXYCODONE HYDROCHLORIDE |
WES PHARMA INC |
Labeling |
Approval |
| 04/06/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #209897 |
SUPPL-3 |
OXYCODONE HYDROCHLORIDE |
WES PHARMA INC |
Labeling |
Approval |
| 04/06/2020 |
CHOLESTYRAMINE
ANDA #211119 |
ORIG-1 |
CHOLESTYRAMINE |
AJANTA PHARMA LTD |
|
Approval |
| 04/06/2020 |
OXYBUTYNIN CHLORIDE
ANDA #212798 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
LEADING |
|
Approval |
| 04/07/2020 |
LUPRON DEPOT-PED KIT
NDA #020263 |
SUPPL-46 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065404 |
SUPPL-6 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065404 |
SUPPL-8 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065404 |
SUPPL-9 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065404 |
SUPPL-13 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065405 |
SUPPL-7 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065405 |
SUPPL-8 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
AZITHROMYCIN
ANDA #065405 |
SUPPL-12 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #079161 |
SUPPL-1 |
ROSUVASTATIN CALCIUM |
STRIDES PHARMA |
Labeling |
Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #079161 |
SUPPL-3 |
ROSUVASTATIN CALCIUM |
STRIDES PHARMA |
Labeling |
Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #079169 |
SUPPL-4 |
ROSUVASTATIN CALCIUM |
SUN PHARM |
Labeling |
Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #079169 |
SUPPL-7 |
ROSUVASTATIN CALCIUM |
SUN PHARM |
Labeling |
Approval |
| 04/07/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #090411 |
SUPPL-6 |
ROPINIROLE HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 04/07/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #090429 |
SUPPL-6 |
ROPINIROLE HYDROCHLORIDE |
ALEMBIC LTD |
Labeling |
Approval |
| 04/07/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #090429 |
SUPPL-7 |
ROPINIROLE HYDROCHLORIDE |
ALEMBIC LTD |
Labeling |
Approval |
| 04/07/2020 |
LOPINAVIR; RITONAVIR
ANDA #090471 |
SUPPL-11 |
LOPINAVIR; RITONAVIR |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/07/2020 |
GLIMEPIRIDE
ANDA #091220 |
SUPPL-14 |
GLIMEPIRIDE |
MICRO LABS |
Labeling |
Approval |
| 04/07/2020 |
SOLIRIS
BLA #125166 |
SUPPL-432 |
ECULIZUMAB |
ALEXION PHARM |
|
Approval |
| 04/07/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #205814 |
SUPPL-1 |
HYDROMORPHONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 04/07/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #205814 |
SUPPL-3 |
HYDROMORPHONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 04/07/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #205814 |
SUPPL-4 |
HYDROMORPHONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 04/07/2020 |
PURIXAN
NDA #205919 |
SUPPL-4 |
MERCAPTOPURINE |
NOVA LABS LTD |
Labeling |
Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #207616 |
SUPPL-1 |
ROSUVASTATIN CALCIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #207616 |
SUPPL-5 |
ROSUVASTATIN CALCIUM |
HETERO LABS LTD V |
Labeling |
Approval |
| 04/07/2020 |
TICAGRELOR
ANDA #208596 |
ORIG-1 |
TICAGRELOR |
SIGMAPHARM LABS LLC |
|
Approval |
| 04/07/2020 |
TICAGRELOR
ANDA #208596 |
ORIG-2 |
TICAGRELOR |
SIGMAPHARM LABS LLC |
|
Tentative Approval |
| 04/07/2020 |
ROSUVASTATIN CALCIUM
ANDA #208850 |
SUPPL-1 |
ROSUVASTATIN CALCIUM |
AMNEAL PHARMS CO |
Labeling |
Approval |
| 04/07/2020 |
FINZALA
ANDA #210087 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TEVA PHARMS USA INC |
|
Approval |
| 04/07/2020 |
GVOKE HYPOPEN
NDA #212097 |
SUPPL-1 |
GLUCAGON |
XERIS |
Labeling |
Approval |
| 04/07/2020 |
GVOKE KIT
NDA #212097 |
SUPPL-1 |
GLUCAGON |
XERIS |
Labeling |
Approval |
| 04/07/2020 |
GVOKE PFS
NDA #212097 |
SUPPL-1 |
GLUCAGON |
XERIS |
Labeling |
Approval |
| 04/07/2020 |
ACYCLOVIR
ANDA #212495 |
ORIG-1 |
ACYCLOVIR |
CHARTWELL RX |
|
Approval |
| 04/07/2020 |
AMITRIPTYLINE HYDROCHLORIDE
ANDA #212654 |
ORIG-1 |
AMITRIPTYLINE HYDROCHLORIDE |
AIPING PHARM INC |
|
Approval |
| 04/07/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #213342 |
ORIG-1 |
HYDROXYCHLOROQUINE SULFATE |
ACCORD HLTHCARE |
|
Approval |
| 04/07/2020 |
STELARA
BLA #761044 |
SUPPL-5 |
USTEKINUMAB |
JANSSEN BIOTECH |
|
Approval |
| 04/08/2020 |
DIDREX
NDA #012427 |
SUPPL-31 |
BENZPHETAMINE HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 04/08/2020 |
AZITHROMYCIN
ANDA #065302 |
SUPPL-5 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/08/2020 |
AZITHROMYCIN
ANDA #065302 |
SUPPL-6 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/08/2020 |
AZITHROMYCIN
ANDA #065302 |
SUPPL-10 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/08/2020 |
DILTIAZEM HYDROCHLORIDE
ANDA #072838 |
SUPPL-23 |
DILTIAZEM HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 04/08/2020 |
ZIDOVUDINE
ANDA #078128 |
SUPPL-12 |
ZIDOVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/08/2020 |
ZIDOVUDINE
ANDA #078128 |
SUPPL-13 |
ZIDOVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/08/2020 |
ZIDOVUDINE
ANDA #078128 |
SUPPL-14 |
ZIDOVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/08/2020 |
ZIDOVUDINE
ANDA #078128 |
SUPPL-15 |
ZIDOVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/08/2020 |
VALSARTAN
ANDA #202696 |
SUPPL-2 |
VALSARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 04/08/2020 |
OPSUMIT
NDA #204410 |
SUPPL-20 |
MACITENTAN |
ACTELION |
REMS |
Approval |
| 04/08/2020 |
AKOVAZ
NDA #208289 |
SUPPL-5 |
EPHEDRINE SULFATE |
EXELA PHARMA |
Labeling |
Approval |
| 04/08/2020 |
ALBUTEROL SULFATE
ANDA #209959 |
ORIG-1 |
ALBUTEROL SULFATE |
CIPLA |
|
Approval |
| 04/08/2020 |
APIXABAN
ANDA #210152 |
ORIG-1 |
APIXABAN |
BIONPHARMA |
|
Approval |
| 04/08/2020 |
BRAFTOVI
NDA #210496 |
SUPPL-6 |
ENCORAFENIB |
ARRAY BIOPHARMA INC |
Efficacy |
Approval |
| 04/08/2020 |
IMATINIB MESYLATE
ANDA #210658 |
ORIG-1 |
IMATINIB MESYLATE |
ZYDUS PHARMS |
|
Approval |
| 04/08/2020 |
MACITENTAN
ANDA #211187 |
ORIG-1 |
MACITENTAN |
TEVA PHARMS USA INC |
|
Tentative Approval |
| 04/08/2020 |
PALBOCICLIB
ANDA #213093 |
ORIG-1 |
PALBOCICLIB |
QILU PHARM CO LTD |
|
Tentative Approval |
| 04/08/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #213286 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/08/2020 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #213321 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
GRANULES |
|
Approval |
| 04/08/2020 |
HYDROXYUREA
ANDA #213438 |
ORIG-1 |
HYDROXYUREA |
LEADING |
|
Approval |
| 04/09/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040274 |
SUPPL-15 |
HYDROXYCHLOROQUINE SULFATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 04/09/2020 |
CARBOPLATIN
ANDA #077266 |
SUPPL-6 |
CARBOPLATIN |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/09/2020 |
TIGECYCLINE
ANDA #091620 |
SUPPL-6 |
TIGECYCLINE |
SANDOZ |
Labeling |
Approval |
| 04/09/2020 |
TIGECYCLINE
ANDA #091620 |
SUPPL-7 |
TIGECYCLINE |
SANDOZ |
Labeling |
Approval |
| 04/09/2020 |
TAFINLAR
NDA #202806 |
SUPPL-15 |
DABRAFENIB MESYLATE |
NOVARTIS |
Labeling |
Approval |
| 04/09/2020 |
NAPROXEN SODIUM
ANDA #202807 |
SUPPL-2 |
NAPROXEN SODIUM |
CATALENT |
Labeling |
Approval |
| 04/09/2020 |
NAPROXEN SODIUM
ANDA #202807 |
SUPPL-3 |
NAPROXEN SODIUM |
CATALENT |
Labeling |
Approval |
| 04/09/2020 |
NYMALIZE
NDA #203340 |
SUPPL-11 |
NIMODIPINE |
AZURITY |
Manufacturing (CMC) |
Approval |
| 04/09/2020 |
UCERIS
NDA #203634 |
SUPPL-7 |
BUDESONIDE |
SALIX |
Labeling |
Approval |
| 04/09/2020 |
MEKINIST
NDA #204114 |
SUPPL-14 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Labeling |
Approval |
| 04/09/2020 |
NAFTIN
NDA #204286 |
SUPPL-4 |
NAFTIFINE HYDROCHLORIDE |
SEBELA IRELAND LTD |
Labeling |
Approval |
| 04/09/2020 |
UCERIS
NDA #205613 |
SUPPL-4 |
BUDESONIDE |
SALIX |
Labeling |
Approval |
| 04/09/2020 |
TOPIRAMATE
ANDA #207382 |
SUPPL-1 |
TOPIRAMATE |
ZYDUS |
Labeling |
Approval |
| 04/09/2020 |
TOPIRAMATE
ANDA #207382 |
SUPPL-2 |
TOPIRAMATE |
ZYDUS |
Labeling |
Approval |
| 04/09/2020 |
INGREZZA
NDA #209241 |
SUPPL-16 |
VALBENAZINE TOSYLATE |
NEUROCRINE |
Labeling |
Approval |
| 04/09/2020 |
DAPAGLIFLOZIN; SAXAGLIPTIN
ANDA #211492 |
ORIG-1 |
DAPAGLIFLOZIN;SAXAGLIPTIN |
SUN PHARM INDS LTD |
|
Tentative Approval |
| 04/09/2020 |
ROPIVACAINE HYDROCHLORIDE
ANDA #212808 |
ORIG-1 |
ROPIVACAINE HYDROCHLORIDE |
CAPLIN |
|
Approval |
| 04/09/2020 |
SEVELAMER CARBONATE
ANDA #212970 |
ORIG-1 |
SEVELAMER CARBONATE |
ANXIN |
|
Approval |
| 04/09/2020 |
METFORMIN HYDROCHLORIDE
ANDA #213651 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
AJANTA PHARMA LTD |
|
Approval |
| 04/10/2020 |
ADVIL
NDA #018989 |
SUPPL-95 |
IBUPROFEN |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 04/10/2020 |
OXALIPLATIN
NDA #022160 |
SUPPL-12 |
OXALIPLATIN |
TEVA PHARMS |
Labeling |
Approval |
| 04/10/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #074597 |
SUPPL-16 |
HYDROMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/10/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #074597 |
SUPPL-18 |
HYDROMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/10/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #074653 |
SUPPL-11 |
HYDROMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/10/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #074653 |
SUPPL-14 |
HYDROMORPHONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/10/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #078932 |
SUPPL-14 |
VENLAFAXINE HYDROCHLORIDE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 04/10/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #079098 |
SUPPL-8 |
VENLAFAXINE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/10/2020 |
MEMANTINE HYDROCHLORIDE
ANDA #202350 |
SUPPL-1 |
MEMANTINE HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/10/2020 |
SEVELAMER CARBONATE
ANDA #203860 |
SUPPL-6 |
SEVELAMER CARBONATE |
INVAGEN PHARMS |
Manufacturing (CMC) |
Approval |
| 04/10/2020 |
OTEZLA
NDA #205437 |
SUPPL-8 |
APREMILAST |
AMGEN INC |
Efficacy |
Approval |
| 04/10/2020 |
TELMISARTAN
ANDA #207882 |
SUPPL-2 |
TELMISARTAN |
PRINSTON INC |
Labeling |
Approval |
| 04/10/2020 |
AZITHROMYCIN
ANDA #209043 |
SUPPL-4 |
AZITHROMYCIN |
SUNSHINE |
Labeling |
Approval |
| 04/10/2020 |
MAVYRET
NDA #209394 |
SUPPL-10 |
GLECAPREVIR; PIBRENTASVIR |
ABBVIE |
Efficacy |
Approval |
| 04/10/2020 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #210764 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
PATRIN |
|
Approval |
| 04/10/2020 |
TURALIO
NDA #211810 |
SUPPL-4 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
Labeling |
Approval |
| 04/10/2020 |
RAMELTEON
ANDA #212650 |
ORIG-1 |
RAMELTEON |
I3 PHARMS |
|
Approval |
| 04/10/2020 |
KOSELUGO
NDA #213756 |
ORIG-1 |
SELUMETINIB SULFATE |
ASTRAZENECA |
Type 1 - New Molecular Entity |
Approval |
| 04/11/2020 |
AZITHROMYCIN
ANDA #090923 |
SUPPL-8 |
AZITHROMYCIN |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/11/2020 |
AZITHROMYCIN
ANDA #090923 |
SUPPL-9 |
AZITHROMYCIN |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/11/2020 |
AZITHROMYCIN
ANDA #090923 |
SUPPL-15 |
AZITHROMYCIN |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/13/2020 |
TAGAMET HB
NDA #020238 |
SUPPL-24 |
CIMETIDINE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 04/13/2020 |
ZONEGRAN
NDA #020789 |
SUPPL-36 |
ZONISAMIDE |
CONCORDIA |
Labeling |
Approval |
| 04/13/2020 |
ZOSYN
NDA #050684 |
SUPPL-95 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 04/13/2020 |
ZOSYN IN PLASTIC CONTAINER
NDA #050750 |
SUPPL-42 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 04/13/2020 |
SUMATRIPTAN SUCCINATE
ANDA #078295 |
SUPPL-18 |
SUMATRIPTAN SUCCINATE |
SUN PHARM INDS |
Labeling |
Approval |
| 04/13/2020 |
OLMESARTAN MEDOXOMIL
ANDA #090237 |
ORIG-1 |
OLMESARTAN MEDOXOMIL |
SANDOZ |
|
Approval |
| 04/13/2020 |
MISOPROSTOL
ANDA #091667 |
SUPPL-3 |
MISOPROSTOL |
NOVEL LABS INC |
Labeling |
Approval |
| 04/13/2020 |
MISOPROSTOL
ANDA #091667 |
SUPPL-6 |
MISOPROSTOL |
NOVEL LABS INC |
Labeling |
Approval |
| 04/13/2020 |
MOVANTIK
NDA #204760 |
SUPPL-9 |
NALOXEGOL OXALATE |
VALINOR |
Labeling |
Approval |
| 04/13/2020 |
LIDOCAINE AND PRILOCAINE
ANDA #205887 |
SUPPL-1 |
LIDOCAINE; PRILOCAINE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
| 04/13/2020 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #208727 |
SUPPL-4 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/13/2020 |
IVERMECTIN
ANDA #210225 |
ORIG-1 |
IVERMECTIN |
PADAGIS ISRAEL |
|
Approval |
| 04/13/2020 |
MACITENTAN
ANDA #211026 |
ORIG-1 |
MACITENTAN |
SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD |
|
Tentative Approval |
| 04/13/2020 |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #211912 |
ORIG-1 |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
CELLTRION INC |
Type 4 - New Combination |
Tentative Approval |
| 04/13/2020 |
DEFERASIROX
ANDA #212995 |
SUPPL-1 |
DEFERASIROX |
PIRAMAL HLTHCARE UK |
Labeling |
Approval |
| 04/13/2020 |
SOLIFENACIN SUCCINATE
ANDA #213346 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
SUNSHINE |
|
Approval |
| 04/13/2020 |
EXEMESTANE
ANDA #213547 |
ORIG-1 |
EXEMESTANE |
QILU |
|
Approval |
| 04/14/2020 |
CLOZARIL
NDA #019758 |
SUPPL-95 |
CLOZAPINE |
HERITAGE LIFE |
Labeling |
Approval |
| 04/14/2020 |
FAZACLO ODT
NDA #021590 |
SUPPL-32 |
CLOZAPINE |
JAZZ |
Labeling |
Approval |
| 04/14/2020 |
CLEOCIN
ANDA #062644 |
SUPPL-31 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 04/14/2020 |
RIFAMPIN
ANDA #065390 |
SUPPL-10 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/14/2020 |
RIFAMPIN
ANDA #065390 |
SUPPL-12 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/14/2020 |
RIFAMPIN
ANDA #065390 |
SUPPL-13 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/14/2020 |
RIFAMPIN
ANDA #065390 |
SUPPL-14 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/14/2020 |
RIFAMPIN
ANDA #065390 |
SUPPL-15 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 04/14/2020 |
TRIAZOLAM
ANDA #074224 |
SUPPL-7 |
TRIAZOLAM |
HIKMA |
Labeling |
Approval |
| 04/14/2020 |
TRIAZOLAM
ANDA #074224 |
SUPPL-9 |
TRIAZOLAM |
HIKMA |
Labeling |
Approval |
| 04/14/2020 |
ENALAPRIL MALEATE
ANDA #075459 |
SUPPL-12 |
ENALAPRIL MALEATE |
SANDOZ INC |
Labeling |
Approval |
| 04/14/2020 |
ENALAPRIL MALEATE
ANDA #075459 |
SUPPL-13 |
ENALAPRIL MALEATE |
SANDOZ INC |
Labeling |
Approval |
| 04/14/2020 |
ENALAPRIL MALEATE
ANDA #075496 |
SUPPL-12 |
ENALAPRIL MALEATE |
SANDOZ INC |
Labeling |
Approval |
| 04/14/2020 |
ENALAPRIL MALEATE
ANDA #075496 |
SUPPL-13 |
ENALAPRIL MALEATE |
SANDOZ INC |
Labeling |
Approval |
| 04/14/2020 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075788 |
SUPPL-16 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
TARO PHARM INDS |
Labeling |
Approval |
| 04/14/2020 |
GLIPIZIDE
ANDA #076159 |
SUPPL-6 |
GLIPIZIDE |
PAR PHARM |
Labeling |
Approval |
| 04/14/2020 |
GLIPIZIDE
ANDA #076159 |
SUPPL-7 |
GLIPIZIDE |
PAR PHARM |
Labeling |
Approval |
| 04/14/2020 |
GLIPIZIDE
ANDA #076159 |
SUPPL-10 |
GLIPIZIDE |
PAR PHARM |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #076690 |
SUPPL-23 |
VENLAFAXINE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #077166 |
SUPPL-17 |
VENLAFAXINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/14/2020 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #077500 |
SUPPL-3 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/14/2020 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #077500 |
SUPPL-4 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/14/2020 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #077500 |
SUPPL-5 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/14/2020 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #077500 |
SUPPL-6 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #077653 |
SUPPL-20 |
VENLAFAXINE HYDROCHLORIDE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL
ANDA #078346 |
SUPPL-3 |
TRANDOLAPRIL |
MYLAN |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL
ANDA #078346 |
SUPPL-4 |
TRANDOLAPRIL |
MYLAN |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL
ANDA #078346 |
SUPPL-5 |
TRANDOLAPRIL |
MYLAN |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135 |
SUPPL-7 |
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135 |
SUPPL-8 |
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135 |
SUPPL-9 |
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/14/2020 |
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135 |
SUPPL-11 |
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #090027 |
SUPPL-14 |
VENLAFAXINE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #090555 |
SUPPL-15 |
VENLAFAXINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #202036 |
SUPPL-2 |
VENLAFAXINE HYDROCHLORIDE |
YAOPHARMA CO LTD |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #202036 |
SUPPL-3 |
VENLAFAXINE HYDROCHLORIDE |
YAOPHARMA CO LTD |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #202036 |
SUPPL-4 |
VENLAFAXINE HYDROCHLORIDE |
YAOPHARMA CO LTD |
Labeling |
Approval |
| 04/14/2020 |
VENLAFAXINE HYDROCHLORIDE
ANDA #202036 |
SUPPL-5 |
VENLAFAXINE HYDROCHLORIDE |
YAOPHARMA CO LTD |
Labeling |
Approval |
| 04/14/2020 |
VERSACLOZ
NDA #203479 |
SUPPL-14 |
CLOZAPINE |
TASMAN PHARMA |
Labeling |
Approval |
| 04/14/2020 |
MACITENTAN
ANDA #211120 |
ORIG-1 |
MACITENTAN |
LAURUS LABS LTD |
|
Tentative Approval |
| 04/14/2020 |
BUPRENORPHINE
ANDA #211586 |
ORIG-1 |
BUPRENORPHINE |
AMNEAL |
|
Approval |
| 04/15/2020 |
AZITHROMYCIN
ANDA #065419 |
SUPPL-13 |
AZITHROMYCIN |
TEVA PHARMS |
Labeling |
Approval |
| 04/15/2020 |
AZITHROMYCIN
ANDA #065419 |
SUPPL-14 |
AZITHROMYCIN |
TEVA PHARMS |
Labeling |
Approval |
| 04/15/2020 |
AZITHROMYCIN
ANDA #065419 |
SUPPL-15 |
AZITHROMYCIN |
TEVA PHARMS |
Labeling |
Approval |
| 04/15/2020 |
NORTRIPTYLINE HYDROCHLORIDE
ANDA #074132 |
SUPPL-28 |
NORTRIPTYLINE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 04/15/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #076723 |
SUPPL-6 |
HYDROMORPHONE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/15/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #076723 |
SUPPL-9 |
HYDROMORPHONE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/15/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #076723 |
SUPPL-10 |
HYDROMORPHONE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/15/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #076723 |
SUPPL-11 |
HYDROMORPHONE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/15/2020 |
CHABELINA FE
ANDA #202962 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
|
Approval |
| 04/15/2020 |
VASOSTRICT
NDA #204485 |
SUPPL-13 |
VASOPRESSIN |
PAR STERILE PRODUCTS |
Manufacturing (CMC) |
Approval |
| 04/15/2020 |
POTASSIUM CHLORIDE
ANDA #204662 |
SUPPL-4 |
POTASSIUM CHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/15/2020 |
CARBAMAZEPINE
ANDA #207798 |
ORIG-1 |
CARBAMAZEPINE |
UMEDICA |
|
Approval |
| 04/15/2020 |
JELMYTO
NDA #211728 |
ORIG-1 |
MITOMYCIN |
UROGEN PHARMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/15/2020 |
PHENYLEPHRINE; KETOROLAC
ANDA #213515 |
ORIG-1 |
PHENYLEPHRINE;KETOROLAC |
GLAND PHARMA LTD |
|
Tentative Approval |
| 04/16/2020 |
FIRAZYR
NDA #022150 |
SUPPL-12 |
ICATIBANT ACETATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/16/2020 |
FIRAZYR
NDA #022150 |
SUPPL-13 |
ICATIBANT ACETATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 04/16/2020 |
AMPICILLIN SODIUM
ANDA #061395 |
SUPPL-47 |
AMPICILLIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/16/2020 |
NORTRIPTYLINE HYDROCHLORIDE
ANDA #075520 |
SUPPL-8 |
NORTRIPTYLINE HYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 04/16/2020 |
PAROXETINE HYDROCHLORIDE
ANDA #078902 |
SUPPL-17 |
PAROXETINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/16/2020 |
PAROXETINE HYDROCHLORIDE
ANDA #078902 |
SUPPL-18 |
PAROXETINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/16/2020 |
RUFINAMIDE
ANDA #204988 |
SUPPL-1 |
RUFINAMIDE |
HIKMA |
Labeling |
Approval |
| 04/16/2020 |
TESTOSTERONE
ANDA #210835 |
ORIG-1 |
TESTOSTERONE |
XIROMED |
|
Approval |
| 04/16/2020 |
ERLOTINIB HYDROCHLORIDE
ANDA #213065 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 04/17/2020 |
HORIZANT
NDA #022399 |
SUPPL-10 |
GABAPENTIN ENACARBIL |
AZURITY |
Labeling |
Approval |
| 04/17/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #090364 |
SUPPL-10 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
WATSON LABS INC |
Labeling |
Approval |
| 04/17/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #090364 |
SUPPL-11 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
WATSON LABS INC |
Labeling |
Approval |
| 04/17/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #090364 |
SUPPL-12 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
WATSON LABS INC |
Labeling |
Approval |
| 04/17/2020 |
ROPINIROLE HYDROCHLORIDE
ANDA #201047 |
SUPPL-11 |
ROPINIROLE HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
| 04/17/2020 |
PHENYLEPHRINE HYDROCHLORIDE
NDA #203510 |
SUPPL-2 |
PHENYLEPHRINE HYDROCHLORIDE |
PARAGON BIOTECK |
Labeling |
Approval |
| 04/17/2020 |
ESOMEPRAZOLE SODIUM
ANDA #205379 |
SUPPL-2 |
ESOMEPRAZOLE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/17/2020 |
ESOMEPRAZOLE SODIUM
ANDA #205379 |
SUPPL-3 |
ESOMEPRAZOLE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/17/2020 |
ESOMEPRAZOLE SODIUM
ANDA #205379 |
SUPPL-4 |
ESOMEPRAZOLE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/17/2020 |
ESOMEPRAZOLE SODIUM
ANDA #205379 |
SUPPL-6 |
ESOMEPRAZOLE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/17/2020 |
ESOMEPRAZOLE SODIUM
ANDA #205379 |
SUPPL-7 |
ESOMEPRAZOLE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/17/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #206118 |
SUPPL-1 |
BETAMETHASONE DIPROPIONATE |
PADAGIS US |
Labeling |
Approval |
| 04/17/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #206118 |
SUPPL-2 |
BETAMETHASONE DIPROPIONATE |
PADAGIS US |
Labeling |
Approval |
| 04/17/2020 |
BUPROPION HYDROCHLORIDE
ANDA #207403 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
MICRO LABS |
|
Approval |
| 04/17/2020 |
VIGABATRIN
ANDA #208218 |
SUPPL-9 |
VIGABATRIN |
PAR PHARM INC |
REMS |
Approval |
| 04/17/2020 |
EZALLOR SPRINKLE
NDA #208647 |
SUPPL-2 |
ROSUVASTATIN CALCIUM |
SUN PHARM |
Labeling |
Approval |
| 04/17/2020 |
ALCAFTADINE
ANDA #209290 |
ORIG-1 |
ALCAFTADINE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 04/17/2020 |
VIGABATRIN
ANDA #209822 |
SUPPL-6 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
| 04/17/2020 |
VIGABATRIN
ANDA #209824 |
SUPPL-8 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
| 04/17/2020 |
VIGABATRIN
ANDA #210155 |
SUPPL-8 |
VIGABATRIN |
AMNEAL PHARMS |
REMS |
Approval |
| 04/17/2020 |
VIGADRONE
ANDA #210196 |
SUPPL-5 |
VIGABATRIN |
AUCTA |
REMS |
Approval |
| 04/17/2020 |
ONPATTRO
NDA #210922 |
SUPPL-7 |
PATISIRAN SODIUM |
ALNYLAM PHARMS INC |
Labeling |
Approval |
| 04/17/2020 |
VIGABATRIN
ANDA #211481 |
SUPPL-4 |
VIGABATRIN |
DR REDDYS |
REMS |
Approval |
| 04/17/2020 |
VIGABATRIN
ANDA #211592 |
SUPPL-2 |
VIGABATRIN |
INVAGEN PHARMS |
REMS |
Approval |
| 04/17/2020 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #211785 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
MYLAN TECHNOLOGIES |
|
Approval |
| 04/17/2020 |
TURALIO
NDA #211810 |
SUPPL-3 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
Labeling |
Approval |
| 04/17/2020 |
FLUCYTOSINE
ANDA #212632 |
ORIG-1 |
FLUCYTOSINE |
STRIDES PHARMA |
|
Approval |
| 04/17/2020 |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #213125 |
ORIG-1 |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
|
Approval |
| 04/17/2020 |
EMERPHED
NDA #213407 |
ORIG-1 |
EPHEDRINE SULFATE |
NEXUS |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/17/2020 |
TUKYSA
NDA #213411 |
ORIG-1 |
TUCATINIB |
SEAGEN |
Type 1 - New Molecular Entity |
Approval |
| 04/17/2020 |
PEMAZYRE
NDA #213736 |
ORIG-1 |
PEMIGATINIB |
INCYTE CORP |
Type 1 - New Molecular Entity |
Approval |
| 04/17/2020 |
DARZALEX
BLA #761036 |
SUPPL-27 |
DARATUMUMAB |
JANSSEN BIOTECH |
|
Approval |
| 04/17/2020 |
TROGARZO
BLA #761065 |
SUPPL-8 |
IBALIZUMAB-UIYK |
THERATECHNOLOGIES |
|
Approval |
| 04/18/2020 |
AZITHROMYCIN
ANDA #065223 |
SUPPL-29 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
| 04/18/2020 |
AZITHROMYCIN
ANDA #065223 |
SUPPL-30 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
| 04/18/2020 |
AZITHROMYCIN
ANDA #065225 |
SUPPL-32 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
| 04/18/2020 |
AZITHROMYCIN
ANDA #065225 |
SUPPL-33 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
| 04/19/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #065470 |
SUPPL-7 |
MINOCYCLINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/19/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #065470 |
SUPPL-8 |
MINOCYCLINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/19/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #065470 |
SUPPL-10 |
MINOCYCLINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/19/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #065470 |
SUPPL-11 |
MINOCYCLINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090339 |
SUPPL-8 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 04/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090339 |
SUPPL-9 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 04/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090349 |
SUPPL-7 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 04/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090349 |
SUPPL-8 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 04/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #201024 |
SUPPL-3 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
STERISCIENCE |
Labeling |
Approval |
| 04/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #201024 |
SUPPL-4 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
STERISCIENCE |
Labeling |
Approval |
| 04/19/2020 |
CARBIDOPA
ANDA #203261 |
SUPPL-5 |
CARBIDOPA |
ANI PHARMS |
Labeling |
Approval |
| 04/19/2020 |
AZITHROMYCIN
ANDA #203412 |
SUPPL-2 |
AZITHROMYCIN |
SLATE RUN PHARMA |
Labeling |
Approval |
| 04/20/2020 |
NIZORAL ANTI-DANDRUFF
NDA #020310 |
SUPPL-24 |
KETOCONAZOLE |
KRAMER |
Labeling |
Approval |
| 04/20/2020 |
CYMBALTA
NDA #021427 |
SUPPL-52 |
DULOXETINE HYDROCHLORIDE |
LILLY |
Efficacy |
Approval |
| 04/20/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063009 |
SUPPL-40 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
| 04/20/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063009 |
SUPPL-41 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
| 04/20/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063009 |
SUPPL-43 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
| 04/20/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063011 |
SUPPL-36 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
| 04/20/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063011 |
SUPPL-37 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
| 04/20/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063011 |
SUPPL-39 |
MINOCYCLINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
| 04/20/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #071196 |
SUPPL-70 |
TRAZODONE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 04/20/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #071196 |
SUPPL-73 |
TRAZODONE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 04/20/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #071258 |
SUPPL-45 |
TRAZODONE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 04/20/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #071258 |
SUPPL-47 |
TRAZODONE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 04/20/2020 |
CHLORHEXIDINE GLUCONATE
ANDA #074356 |
SUPPL-15 |
CHLORHEXIDINE GLUCONATE |
AKORN |
Labeling |
Approval |
| 04/20/2020 |
CARBAMAZEPINE
ANDA #075948 |
SUPPL-12 |
CARBAMAZEPINE |
APOTEX INC |
Labeling |
Approval |
| 04/20/2020 |
CARBAMAZEPINE
ANDA #075948 |
SUPPL-14 |
CARBAMAZEPINE |
APOTEX INC |
Labeling |
Approval |
| 04/20/2020 |
PAROXETINE HYDROCHLORIDE
ANDA #076618 |
SUPPL-21 |
PAROXETINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 04/20/2020 |
CITALOPRAM HYDROBROMIDE
ANDA #201450 |
SUPPL-3 |
CITALOPRAM HYDROBROMIDE |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #203308 |
SUPPL-2 |
LEVETIRACETAM |
MYLAN LABS LTD |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #203308 |
SUPPL-3 |
LEVETIRACETAM |
MYLAN LABS LTD |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #203308 |
SUPPL-7 |
LEVETIRACETAM |
MYLAN LABS LTD |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #204312 |
SUPPL-2 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #204312 |
SUPPL-4 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #204312 |
SUPPL-6 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM
ANDA #204312 |
SUPPL-8 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 04/20/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #205253 |
SUPPL-4 |
TRAZODONE HYDROCHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
| 04/20/2020 |
PANTOPRAZOLE SODIUM
ANDA #205675 |
SUPPL-12 |
PANTOPRAZOLE SODIUM |
EUGIA PHARMA |
Manufacturing (CMC) |
Approval |
| 04/20/2020 |
LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #206880 |
SUPPL-4 |
LEVETIRACETAM |
GLAND PHARMA LTD |
Labeling |
Approval |
| 04/20/2020 |
LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #206880 |
SUPPL-5 |
LEVETIRACETAM |
GLAND PHARMA LTD |
Labeling |
Approval |
| 04/20/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #208333 |
SUPPL-2 |
ESOMEPRAZOLE MAGNESIUM |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/20/2020 |
AMBRISENTAN
ANDA #210058 |
SUPPL-3 |
AMBRISENTAN |
ZYDUS PHARMS |
REMS |
Approval |
| 04/20/2020 |
AMBRISENTAN
ANDA #210715 |
SUPPL-2 |
AMBRISENTAN |
CIPLA |
REMS |
Approval |
| 04/20/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #210729 |
SUPPL-1 |
VANCOMYCIN HYDROCHLORIDE |
ORIENT PHARMA CO LTD |
Manufacturing (CMC) |
Approval |
| 04/20/2020 |
ALBUTEROL SULFATE
ANDA #211888 |
ORIG-1 |
ALBUTEROL SULFATE |
LUOXIN AUROVITAS |
|
Approval |
| 04/20/2020 |
COLESEVELAM HYDROCHLORIDE
ANDA #212602 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
INVAGEN PHARMS |
|
Approval |
| 04/21/2020 |
ZYPREXA
NDA #020592 |
SUPPL-75 |
OLANZAPINE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/21/2020 |
ZYPREXA ZYDIS
NDA #021086 |
SUPPL-49 |
OLANZAPINE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/21/2020 |
ZYPREXA
NDA #021253 |
SUPPL-62 |
OLANZAPINE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/21/2020 |
SYMBYAX
NDA #021520 |
SUPPL-53 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
LILLY |
Labeling |
Approval |
| 04/21/2020 |
ZYPREXA RELPREVV
NDA #022173 |
SUPPL-36 |
OLANZAPINE PAMOATE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/21/2020 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075624 |
SUPPL-26 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
RISING |
Labeling |
Approval |
| 04/21/2020 |
VALPROIC ACID
ANDA #077105 |
SUPPL-11 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/21/2020 |
VALPROIC ACID
ANDA #077105 |
SUPPL-12 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/21/2020 |
VALPROIC ACID
ANDA #077105 |
SUPPL-13 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/21/2020 |
VALPROIC ACID
ANDA #077105 |
SUPPL-14 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/21/2020 |
VALPROIC ACID
ANDA #077105 |
SUPPL-15 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/21/2020 |
VALPROIC ACID
ANDA #077105 |
SUPPL-16 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 04/21/2020 |
VALPROATE SODIUM
ANDA #078523 |
SUPPL-10 |
VALPROATE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/21/2020 |
VALPROATE SODIUM
ANDA #078523 |
SUPPL-11 |
VALPROATE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/21/2020 |
VALPROATE SODIUM
ANDA #078523 |
SUPPL-12 |
VALPROATE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/21/2020 |
VALPROATE SODIUM
ANDA #078523 |
SUPPL-13 |
VALPROATE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/21/2020 |
VALPROATE SODIUM
ANDA #078523 |
SUPPL-15 |
VALPROATE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 04/21/2020 |
TYSABRI
BLA #125104 |
SUPPL-967 |
NATALIZUMAB |
BIOGEN IDEC |
|
Approval |
| 04/21/2020 |
ESTRADIOL VALERATE
ANDA #203723 |
ORIG-1 |
ESTRADIOL VALERATE |
HIKMA |
|
Approval |
| 04/21/2020 |
IMBRUVICA
NDA #205552 |
SUPPL-30 |
IBRUTINIB |
PHARMACYCLICS LLC |
Efficacy |
Approval |
| 04/21/2020 |
SAVAYSA
NDA #206316 |
SUPPL-16 |
EDOXABAN TOSYLATE |
DAIICHI SANKYO INC |
Labeling |
Approval |
| 04/21/2020 |
CLOCORTOLONE PIVALATE
ANDA #206370 |
ORIG-1 |
CLOCORTOLONE PIVALATE |
TARO |
|
Approval |
| 04/21/2020 |
IMBRUVICA
NDA #210563 |
SUPPL-6 |
IBRUTINIB |
PHARMACYCLICS LLC |
Efficacy |
Approval |
| 04/22/2020 |
ZYPREXA RELPREVV
NDA #022173 |
SUPPL-35 |
OLANZAPINE PAMOATE |
CHEPLAPHARM |
REMS |
Approval |
| 04/22/2020 |
CARISOPRODOL
ANDA #040397 |
SUPPL-7 |
CARISOPRODOL |
EPIC PHARMA LLC |
Labeling |
Approval |
| 04/22/2020 |
CARISOPRODOL
ANDA #040397 |
SUPPL-8 |
CARISOPRODOL |
EPIC PHARMA LLC |
Labeling |
Approval |
| 04/22/2020 |
DOXY 100
ANDA #062475 |
SUPPL-49 |
DOXYCYCLINE HYCLATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/22/2020 |
DOXY 100
ANDA #062475 |
SUPPL-50 |
DOXYCYCLINE HYCLATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/22/2020 |
DOXY 200
ANDA #062475 |
SUPPL-49 |
DOXYCYCLINE HYCLATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/22/2020 |
DOXY 200
ANDA #062475 |
SUPPL-50 |
DOXYCYCLINE HYCLATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/22/2020 |
LORAZEPAM
ANDA #074282 |
SUPPL-18 |
LORAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 04/22/2020 |
LORAZEPAM
ANDA #074282 |
SUPPL-19 |
LORAZEPAM |
HOSPIRA |
Labeling |
Approval |
| 04/22/2020 |
TRIMETHOBENZAMIDE HYDROCHLORIDE
ANDA #076546 |
SUPPL-10 |
TRIMETHOBENZAMIDE HYDROCHLORIDE |
LUPIN |
Labeling |
Approval |
| 04/22/2020 |
TRIMETHOBENZAMIDE HYDROCHLORIDE
ANDA #076570 |
SUPPL-18 |
TRIMETHOBENZAMIDE HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/22/2020 |
ARGATROBAN
NDA #203049 |
SUPPL-7 |
ARGATROBAN |
HIKMA PHARM CO LTD |
Labeling |
Approval |
| 04/22/2020 |
LEVOFLOXACIN
ANDA #205540 |
ORIG-1 |
LEVOFLOXACIN |
GLAND PHARMA LTD |
|
Approval |
| 04/22/2020 |
EVOTAZ
NDA #206353 |
SUPPL-6 |
ATAZANAVIR SULFATE; COBICISTAT |
BRISTOL |
Labeling |
Approval |
| 04/22/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #207108 |
ORIG-1 |
HYDROMORPHONE HYDROCHLORIDE |
GENUS |
|
Approval |
| 04/22/2020 |
ENDARI
NDA #208587 |
SUPPL-2 |
L-GLUTAMINE |
EMMAUS MEDCL |
Labeling |
Approval |
| 04/22/2020 |
TRODELVY
BLA #761115 |
ORIG-1 |
SACITUZUMAB GOVITECAN-HZIY |
IMMUNOMEDICS INC |
|
Approval |
| 04/23/2020 |
ALEVE
NDA #020204 |
SUPPL-71 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
| 04/23/2020 |
ZYPREXA
NDA #020592 |
SUPPL-74 |
OLANZAPINE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/23/2020 |
ZYPREXA ZYDIS
NDA #021086 |
SUPPL-48 |
OLANZAPINE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/23/2020 |
ZYPREXA
NDA #021253 |
SUPPL-61 |
OLANZAPINE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/23/2020 |
ZYPREXA RELPREVV
NDA #022173 |
SUPPL-34 |
OLANZAPINE PAMOATE |
CHEPLAPHARM |
Labeling |
Approval |
| 04/23/2020 |
PROLIA
BLA #125320 |
SUPPL-205 |
DENOSUMAB |
AMGEN |
|
Approval |
| 04/23/2020 |
XGEVA
BLA #125320 |
SUPPL-205 |
DENOSUMAB |
AMGEN |
|
Approval |
| 04/23/2020 |
SILDENAFIL CITRATE
ANDA #205791 |
ORIG-1 |
SILDENAFIL CITRATE |
PERRIGO R AND D |
|
Approval |
| 04/23/2020 |
LENVIMA
NDA #206947 |
SUPPL-13 |
LENVATINIB MESYLATE |
EISAI INC |
Labeling |
Approval |
| 04/23/2020 |
XHANCE
NDA #209022 |
SUPPL-9 |
FLUTICASONE PROPIONATE |
OPTINOSE US INC |
Labeling |
Approval |
| 04/23/2020 |
LEXETTE
NDA #210566 |
SUPPL-2 |
HALOBETASOL PROPIONATE |
MAYNE PHARMA |
Labeling |
Approval |
| 04/23/2020 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #211968 |
ORIG-1 |
SODIUM CHLORIDE |
NEPHRON |
|
Approval |
| 04/23/2020 |
ACYCLOVIR
ANDA #212718 |
ORIG-1 |
ACYCLOVIR |
CHARTWELL RX |
|
Approval |
| 04/23/2020 |
TROSPIUM CHLORIDE
ANDA #213185 |
ORIG-1 |
TROSPIUM CHLORIDE |
GRANULES |
|
Approval |
| 04/24/2020 |
NEUPRO
NDA #021829 |
SUPPL-17 |
ROTIGOTINE |
UCB INC |
Labeling |
Approval |
| 04/24/2020 |
CARISOPRODOL
ANDA #040823 |
SUPPL-2 |
CARISOPRODOL |
NOVAST LABS |
Labeling |
Approval |
| 04/24/2020 |
TOBREX
NDA #050541 |
SUPPL-30 |
TOBRAMYCIN |
NOVARTIS |
Labeling |
Approval |
| 04/24/2020 |
TOBREX
NDA #050555 |
SUPPL-37 |
TOBRAMYCIN |
NOVARTIS |
Labeling |
Approval |
| 04/24/2020 |
TOBRADEX
NDA #050592 |
SUPPL-43 |
DEXAMETHASONE; TOBRAMYCIN |
SANDOZ |
Labeling |
Approval |
| 04/24/2020 |
TOBRADEX
NDA #050616 |
SUPPL-39 |
DEXAMETHASONE; TOBRAMYCIN |
NOVARTIS |
Labeling |
Approval |
| 04/24/2020 |
MEMANTINE HYDROCHLORIDE
ANDA #200022 |
SUPPL-3 |
MEMANTINE HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 04/24/2020 |
CYSTARAN
NDA #200740 |
SUPPL-1 |
CYSTEAMINE HYDROCHLORIDE |
LEADIANT BIOSCI INC |
Labeling |
Approval |
| 04/24/2020 |
XULANE
ANDA #200910 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORELGESTROMIN |
MYLAN TECHNOLOGIES |
Labeling |
Approval |
| 04/24/2020 |
NICOTINE POLACRILEX
ANDA #206394 |
SUPPL-9 |
NICOTINE POLACRILEX |
PERRIGO R AND D |
Manufacturing (CMC) |
Approval |
| 04/24/2020 |
LOKELMA
NDA #207078 |
SUPPL-3 |
SODIUM ZIRCONIUM CYCLOSILICATE |
ASTRAZENECA |
Efficacy |
Approval |
| 04/24/2020 |
DEFERASIROX
ANDA #209223 |
ORIG-2 |
DEFERASIROX |
TEVA PHARMS USA |
|
Approval |
| 04/24/2020 |
INVELTYS
NDA #210565 |
SUPPL-3 |
LOTEPREDNOL ETABONATE |
ALCON LABS INC |
Labeling |
Approval |
| 04/24/2020 |
CARBAMAZEPINE
ANDA #211623 |
ORIG-1 |
CARBAMAZEPINE |
UNIQUE PHARM |
|
Approval |
| 04/24/2020 |
EPINEPHRINE
ANDA #211880 |
ORIG-1 |
EPINEPHRINE |
INTL MEDICATION SYS |
|
Approval |
| 04/24/2020 |
ONGENTYS
NDA #212489 |
ORIG-1 |
OPICAPONE |
NEUROCRINE |
Type 1 - New Molecular Entity |
Approval |
| 04/24/2020 |
CLOBAZAM
ANDA #213110 |
ORIG-1 |
CLOBAZAM |
CHARTWELL MOLECULAR |
|
Approval |
| 04/24/2020 |
VIGABATRIN
ANDA #213469 |
ORIG-1 |
VIGABATRIN |
GRANULES |
|
Approval |
| 04/26/2020 |
ULESFIA
NDA #022129 |
SUPPL-8 |
BENZYL ALCOHOL |
SHIONOGI INC |
Labeling |
Approval |
| 04/26/2020 |
JUBLIA
NDA #203567 |
SUPPL-9 |
EFINACONAZOLE |
BAUSCH |
Efficacy |
Approval |
| 04/26/2020 |
POTASSIUM CHLORIDE
ANDA #205993 |
SUPPL-3 |
POTASSIUM CHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 04/27/2020 |
METRONIDAZOLE
NDA #018620 |
SUPPL-21 |
METRONIDAZOLE |
FOSUN PHARMA |
Labeling |
Approval |
| 04/27/2020 |
METRONIDAZOLE
NDA #018740 |
SUPPL-39 |
METRONIDAZOLE |
FOSUN PHARMA |
Labeling |
Approval |
| 04/27/2020 |
METRONIDAZOLE
NDA #018845 |
SUPPL-14 |
METRONIDAZOLE |
CHARTWELL MOLECULES |
Labeling |
Approval |
| 04/27/2020 |
METRONIDAZOLE
NDA #018930 |
SUPPL-13 |
METRONIDAZOLE |
CHARTWELL MOLECULES |
Labeling |
Approval |
| 04/27/2020 |
IDARUBICIN HYDROCHLORIDE
ANDA #065036 |
SUPPL-27 |
IDARUBICIN HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 04/27/2020 |
IDARUBICIN HYDROCHLORIDE
ANDA #065036 |
SUPPL-30 |
IDARUBICIN HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 04/27/2020 |
LISINOPRIL
ANDA #075743 |
SUPPL-32 |
LISINOPRIL |
PRINSTON INC |
Labeling |
Approval |
| 04/27/2020 |
LISINOPRIL
ANDA #075903 |
SUPPL-20 |
LISINOPRIL |
ASCENT PHARMS INC |
Labeling |
Approval |
| 04/27/2020 |
LISINOPRIL
ANDA #075944 |
SUPPL-29 |
LISINOPRIL |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 04/27/2020 |
MOMETASONE FUROATE
ANDA #076171 |
SUPPL-4 |
MOMETASONE FUROATE |
FOUGERA PHARMS |
Labeling |
Approval |
| 04/27/2020 |
LISINOPRIL
ANDA #077321 |
SUPPL-38 |
LISINOPRIL |
LUPIN |
Labeling |
Approval |
| 04/27/2020 |
LISINOPRIL
ANDA #077321 |
SUPPL-41 |
LISINOPRIL |
LUPIN |
Labeling |
Approval |
| 04/27/2020 |
CARISOPRODOL
ANDA #087499 |
SUPPL-55 |
CARISOPRODOL |
WATSON LABS |
Labeling |
Approval |
| 04/27/2020 |
CARISOPRODOL
ANDA #087499 |
SUPPL-58 |
CARISOPRODOL |
WATSON LABS |
Labeling |
Approval |
| 04/27/2020 |
ESZOPICLONE
ANDA #091113 |
SUPPL-3 |
ESZOPICLONE |
ORBION PHARMS |
Labeling |
Approval |
| 04/27/2020 |
ESZOPICLONE
ANDA #091113 |
SUPPL-4 |
ESZOPICLONE |
ORBION PHARMS |
Labeling |
Approval |
| 04/27/2020 |
ESZOPICLONE
ANDA #091113 |
SUPPL-6 |
ESZOPICLONE |
ORBION PHARMS |
Labeling |
Approval |
| 04/27/2020 |
IMIPRAMINE PAMOATE
ANDA #202338 |
SUPPL-2 |
IMIPRAMINE PAMOATE |
RISING |
Labeling |
Approval |
| 04/27/2020 |
CARISOPRODOL
ANDA #205085 |
SUPPL-3 |
CARISOPRODOL |
ORIENT PHARMA CO LTD |
Labeling |
Approval |
| 04/27/2020 |
LILETTA
NDA #206229 |
SUPPL-10 |
LEVONORGESTREL |
MEDICINES360 |
Labeling |
Approval |
| 04/27/2020 |
MUPIROCIN
ANDA #207116 |
ORIG-1 |
MUPIROCIN CALCIUM |
TARO |
|
Approval |
| 04/27/2020 |
LOPINAVIR AND RITONAVIR
ANDA #207407 |
SUPPL-1 |
LOPINAVIR; RITONAVIR |
LANNETT CO INC |
Labeling |
Approval |
| 04/27/2020 |
LOPINAVIR AND RITONAVIR
ANDA #207407 |
SUPPL-2 |
LOPINAVIR; RITONAVIR |
LANNETT CO INC |
Labeling |
Approval |
| 04/27/2020 |
LOPINAVIR AND RITONAVIR
ANDA #207407 |
SUPPL-3 |
LOPINAVIR; RITONAVIR |
LANNETT CO INC |
Labeling |
Approval |
| 04/27/2020 |
LOPINAVIR AND RITONAVIR
ANDA #207407 |
SUPPL-4 |
LOPINAVIR; RITONAVIR |
LANNETT CO INC |
Labeling |
Approval |
| 04/27/2020 |
LOPINAVIR AND RITONAVIR
ANDA #207407 |
SUPPL-5 |
LOPINAVIR; RITONAVIR |
LANNETT CO INC |
Labeling |
Approval |
| 04/27/2020 |
POTASSIUM CHLORIDE
ANDA #207528 |
SUPPL-1 |
POTASSIUM CHLORIDE |
SIGMAPHARM LABS LLC |
Labeling |
Approval |
| 04/27/2020 |
DAPAGLIFLOZIN; SAXAGLIPTIN
ANDA #211565 |
ORIG-1 |
DAPAGLIFLOZIN;SAXAGLIPTIN |
GLENMARK GENERICS |
|
Tentative Approval |
| 04/27/2020 |
CAPECITABINE
ANDA #211724 |
ORIG-1 |
CAPECITABINE |
RELIANCE LIFE |
|
Approval |
| 04/28/2020 |
PROZAC
NDA #018936 |
SUPPL-109 |
FLUOXETINE HYDROCHLORIDE |
ELI LILLY AND CO |
Labeling |
Approval |
| 04/28/2020 |
SARAFEM
NDA #018936 |
SUPPL-109 |
FLUOXETINE HYDROCHLORIDE |
ELI LILLY AND CO |
Labeling |
Approval |
| 04/28/2020 |
PROMACTA
NDA #022291 |
SUPPL-26 |
ELTROMBOPAG OLAMINE |
NOVARTIS |
Labeling |
Approval |
| 04/28/2020 |
CHLOROQUINE PHOSPHATE
ANDA #040516 |
SUPPL-11 |
CHLOROQUINE PHOSPHATE |
IMPAX LABS |
Labeling |
Approval |
| 04/28/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040760 |
SUPPL-7 |
HYDROXYCHLOROQUINE SULFATE |
HIKMA PHARMS |
Labeling |
Approval |
| 04/28/2020 |
MYFORTIC
NDA #050791 |
SUPPL-30 |
MYCOPHENOLIC SODIUM |
NOVARTIS |
Labeling |
Approval |
| 04/28/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #072483 |
SUPPL-13 |
TRAZODONE HYDROCHLORIDE |
FOSUN PHARMA |
Labeling |
Approval |
| 04/28/2020 |
KETAMINE HYDROCHLORIDE
ANDA #074549 |
SUPPL-19 |
KETAMINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 04/28/2020 |
LORYNA
ANDA #079221 |
SUPPL-11 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/28/2020 |
LORYNA
ANDA #079221 |
SUPPL-13 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/28/2020 |
LORYNA
ANDA #079221 |
SUPPL-14 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
| 04/28/2020 |
NORETHINDRONE
ANDA #091325 |
SUPPL-8 |
NORETHINDRONE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-59 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-60 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-61 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-62 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-63 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-64 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-69 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-76 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-77 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-78 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-79 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-80 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-81 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-82 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
KEYTRUDA
BLA #125514 |
SUPPL-83 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 04/28/2020 |
CARISOPRODOL
ANDA #205126 |
SUPPL-5 |
CARISOPRODOL |
WILSHIRE PHARMS INC |
Labeling |
Approval |
| 04/28/2020 |
DILTIAZEM HYDROCHLORIDE
ANDA #206997 |
ORIG-1 |
DILTIAZEM HYDROCHLORIDE |
ACCORD HLTHCARE |
|
Approval |
| 04/28/2020 |
SINUVA
NDA #209310 |
SUPPL-3 |
MOMETASONE FUROATE |
INTERSECT ENT INC |
Efficacy |
Approval |
| 04/28/2020 |
BAFIERTAM
NDA #210296 |
ORIG-1 |
MONOMETHYL FUMARATE |
BANNER LIFE SCIENCES |
Type 2 - New Active Ingredient |
Approval |
| 04/28/2020 |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #212542 |
ORIG-1 |
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
SUN PHARM INDS INC |
|
Approval |
| 04/28/2020 |
PENICILLAMINE
ANDA #213310 |
ORIG-1 |
PENICILLAMINE |
APOTEX |
|
Approval |
| 04/29/2020 |
PURINETHOL
NDA #009053 |
SUPPL-39 |
MERCAPTOPURINE |
STASON PHARMS |
Labeling |
Approval |
| 04/29/2020 |
MANNITOL 10% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-40 |
MANNITOL |
ICU MEDICAL INC |
Efficacy |
Approval |
| 04/29/2020 |
MANNITOL 15% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-40 |
MANNITOL |
ICU MEDICAL INC |
Efficacy |
Approval |
| 04/29/2020 |
MANNITOL 20% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-40 |
MANNITOL |
ICU MEDICAL INC |
Efficacy |
Approval |
| 04/29/2020 |
MANNITOL 5% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-40 |
MANNITOL |
ICU MEDICAL INC |
Efficacy |
Approval |
| 04/29/2020 |
REMERON
NDA #020415 |
SUPPL-34 |
MIRTAZAPINE |
ORGANON |
Labeling |
Approval |
| 04/29/2020 |
REMERON
NDA #020415 |
SUPPL-36 |
MIRTAZAPINE |
ORGANON |
Labeling |
Approval |
| 04/29/2020 |
SINGULAIR
NDA #020829 |
SUPPL-73 |
MONTELUKAST SODIUM |
ORGANON |
Labeling |
Approval |
| 04/29/2020 |
SINGULAIR
NDA #020830 |
SUPPL-75 |
MONTELUKAST SODIUM |
ORGANON |
Labeling |
Approval |
| 04/29/2020 |
REMERON SOLTAB
NDA #021208 |
SUPPL-24 |
MIRTAZAPINE |
ORGANON USA ORGANON |
Labeling |
Approval |
| 04/29/2020 |
REMERON SOLTAB
NDA #021208 |
SUPPL-26 |
MIRTAZAPINE |
ORGANON USA ORGANON |
Labeling |
Approval |
| 04/29/2020 |
SINGULAIR
NDA #021409 |
SUPPL-51 |
MONTELUKAST SODIUM |
ORGANON |
Labeling |
Approval |
| 04/29/2020 |
RECLAST
NDA #021817 |
SUPPL-28 |
ZOLEDRONIC ACID |
SANDOZ |
Labeling |
Approval |
| 04/29/2020 |
PROMACTA
NDA #022291 |
SUPPL-27 |
ELTROMBOPAG OLAMINE |
NOVARTIS |
Labeling |
Approval |
| 04/29/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065310 |
SUPPL-19 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065310 |
SUPPL-21 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #071405 |
SUPPL-6 |
TRAZODONE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/29/2020 |
DILTIAZEM HYDROCHLORIDE
ANDA #074185 |
SUPPL-18 |
DILTIAZEM HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 04/29/2020 |
DILTIAZEM HYDROCHLORIDE
ANDA #074185 |
SUPPL-21 |
DILTIAZEM HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 04/29/2020 |
LISINOPRIL
ANDA #076102 |
SUPPL-16 |
LISINOPRIL |
COREPHARMA |
Labeling |
Approval |
| 04/29/2020 |
MILPROSA
NDA #201110 |
ORIG-1 |
PROGESTERONE |
FERRING PHARMS INC |
Type 3 - New Dosage Form |
Approval |
| 04/29/2020 |
PAROXETINE
ANDA #203854 |
SUPPL-1 |
PAROXETINE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 04/29/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #205853 |
ORIG-1 |
OXYCODONE HYDROCHLORIDE |
RHODES PHARMS |
|
Approval |
| 04/29/2020 |
PROMACTA KIT
NDA #207027 |
SUPPL-10 |
ELTROMBOPAG OLAMINE |
NOVARTIS |
Labeling |
Approval |
| 04/29/2020 |
ZEJULA
NDA #208447 |
SUPPL-15 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 04/29/2020 |
ZEJULA
NDA #208447 |
SUPPL-17 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Efficacy |
Approval |
| 04/29/2020 |
OMEPRAZOLE
NDA #209400 |
SUPPL-7 |
OMEPRAZOLE |
DEXCEL |
Labeling |
Approval |
| 04/29/2020 |
RANOLAZINE
ANDA #211707 |
SUPPL-2 |
RANOLAZINE |
SUN PHARM |
Labeling |
Approval |
| 04/29/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #213513 |
ORIG-1 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
HETERO LABS LTD III |
|
Approval |
| 04/30/2020 |
RENAGEL
NDA #021179 |
SUPPL-38 |
SEVELAMER HYDROCHLORIDE |
GENZYME |
Labeling |
Approval |
| 04/30/2020 |
NAPROXEN SODIUM
NDA #021920 |
SUPPL-28 |
NAPROXEN SODIUM |
BIONPHARMA |
Labeling |
Approval |
| 04/30/2020 |
RENVELA
NDA #022127 |
SUPPL-19 |
SEVELAMER CARBONATE |
SANOFI |
Labeling |
Approval |
| 04/30/2020 |
SANCUSO
NDA #022198 |
SUPPL-20 |
GRANISETRON |
CUMBERLAND |
Labeling |
Approval |
| 04/30/2020 |
RENVELA
NDA #022318 |
SUPPL-12 |
SEVELAMER CARBONATE |
GENZYME |
Labeling |
Approval |
| 04/30/2020 |
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #078833 |
SUPPL-14 |
DROSPIRENONE; ETHINYL ESTRADIOL |
WATSON LABS |
Labeling |
Approval |
| 04/30/2020 |
CHLOROQUINE PHOSPHATE
ANDA #080880 |
SUPPL-63 |
CHLOROQUINE PHOSPHATE |
IMPAX LABS |
Labeling |
Approval |
| 04/30/2020 |
VOGELXO
NDA #204399 |
SUPPL-12 |
TESTOSTERONE |
UPSHER SMITH LABS |
Labeling |
Approval |
| 04/30/2020 |
ACETAZOLAMIDE
ANDA #207503 |
ORIG-1 |
ACETAZOLAMIDE |
BRECKENRIDGE |
|
Approval |
| 04/30/2020 |
LIDOCAINE
ANDA #209190 |
ORIG-1 |
LIDOCAINE |
IBSA |
|
Approval |
| 04/30/2020 |
EMPAGLIFLOZIN
ANDA #212283 |
ORIG-1 |
EMPAGLIFLOZIN |
MANKIND PHARMA |
|
Tentative Approval |
| 04/30/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #212587 |
ORIG-1 |
OMEPRAZOLE; SODIUM BICARBONATE |
ANDA REPOSITORY |
|
Approval |
| 04/30/2020 |
AIMOVIG
BLA #761077 |
SUPPL-7 |
ERENUMAB-AOOE |
AMGEN INC |
|
Approval |
| 04/30/2020 |
ULTOMIRIS
BLA #761108 |
SUPPL-7 |
RAVULIZUMAB-CWVZ |
ALEXION PHARM |
|
Approval |
