05/01/2019 |
DIPROLENE NDA #018741 |
SUPPL-40 |
BETAMETHASONE DIPROPIONATE |
ORGANON |
Labeling |
Approval |
05/01/2019 |
DIPROLENE AF NDA #019555 |
SUPPL-35 |
BETAMETHASONE DIPROPIONATE |
ORGANON |
Labeling |
Approval |
05/01/2019 |
DIPROLENE NDA #019716 |
SUPPL-33 |
BETAMETHASONE DIPROPIONATE |
ORGANON |
Labeling |
Approval |
05/01/2019 |
NORMOCARB HF 25 NDA #021910 |
SUPPL-8 |
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
DIALYSIS SUPS |
Labeling |
Approval |
05/01/2019 |
NORMOCARB HF 35 NDA #021910 |
SUPPL-8 |
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
DIALYSIS SUPS |
Labeling |
Approval |
05/01/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #079160 |
SUPPL-9 |
GEMCITABINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
05/01/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #079160 |
SUPPL-10 |
GEMCITABINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
05/01/2019 |
LAMIVUDINE ANDA #090198 |
ORIG-1 |
LAMIVUDINE |
MACLEODS PHARMS LTD |
|
Approval |
05/01/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #091365 |
SUPPL-7 |
GEMCITABINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/01/2019 |
BLISOVI 24 FE ANDA #091398 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Labeling |
Approval |
05/01/2019 |
BLISOVI 24 FE ANDA #091398 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Labeling |
Approval |
05/01/2019 |
BLISOVI 24 FE ANDA #091398 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
05/01/2019 |
XOLAIR BLA #103976 |
SUPPL-5234 |
OMALIZUMAB |
GENENTECH |
|
Approval |
05/01/2019 |
NADOLOL ANDA #201893 |
SUPPL-1 |
NADOLOL |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
05/01/2019 |
DACTINOMYCIN ANDA #203385 |
SUPPL-1 |
DACTINOMYCIN |
EUGIA PHARMA |
Labeling |
Approval |
05/01/2019 |
POTASSIUM CHLORIDE NDA #206814 |
SUPPL-8 |
POTASSIUM CHLORIDE |
GENUS LIFESCIENCES |
Manufacturing (CMC) |
Approval |
05/01/2019 |
DAPTOMYCIN ANDA #208375 |
ORIG-1 |
DAPTOMYCIN |
DR REDDYS |
|
Approval |
05/01/2019 |
MEDROXYPROGESTERONE ACETATE ANDA #210760 |
ORIG-1 |
MEDROXYPROGESTERONE ACETATE |
SUN PHARM |
|
Approval |
05/01/2019 |
CALCIUM CHLORIDE 10% ANDA #211553 |
ORIG-1 |
CALCIUM CHLORIDE |
MEDEFIL INC |
|
Approval |
05/02/2019 |
ETOPOPHOS PRESERVATIVE FREE NDA #020457 |
SUPPL-19 |
ETOPOSIDE PHOSPHATE |
CHEPLAPHARM |
Labeling |
Approval |
05/02/2019 |
TOPAMAX NDA #020505 |
SUPPL-60 |
TOPIRAMATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/02/2019 |
TOPAMAX NDA #020844 |
SUPPL-51 |
TOPIRAMATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/02/2019 |
TOPAMAX SPRINKLE NDA #020844 |
SUPPL-51 |
TOPIRAMATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/02/2019 |
REBETOL NDA #020903 |
SUPPL-55 |
RIBAVIRIN |
MERCK SHARP DOHME |
Labeling |
Approval |
05/02/2019 |
REBETOL NDA #021546 |
SUPPL-11 |
RIBAVIRIN |
SCHERING |
Labeling |
Approval |
05/02/2019 |
KUVAN NDA #022181 |
SUPPL-19 |
SAPROPTERIN DIHYDROCHLORIDE |
BIOMARIN PHARM |
Labeling |
Approval |
05/02/2019 |
PREDNISONE ANDA #088832 |
SUPPL-35 |
PREDNISONE |
MYLAN |
Manufacturing (CMC) |
Approval |
05/02/2019 |
OPDIVO BLA #125554 |
SUPPL-73 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
05/02/2019 |
BLISOVI FE 1.5/30 ANDA #201585 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Labeling |
Approval |
05/02/2019 |
BLISOVI FE 1.5/30 ANDA #201585 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
05/02/2019 |
KUVAN NDA #205065 |
SUPPL-5 |
SAPROPTERIN DIHYDROCHLORIDE |
BIOMARIN PHARM |
Labeling |
Approval |
05/02/2019 |
TIMOLOL MALEATE ANDA #207556 |
ORIG-1 |
TIMOLOL MALEATE |
RISING PHARMA |
|
Approval |
05/02/2019 |
LEVONORGESTREL ANDA #207660 |
ORIG-1 |
LEVONORGESTREL |
NAARI PTE LTD |
|
Approval |
05/02/2019 |
QTERN NDA #209091 |
SUPPL-2 |
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE |
ASTRAZENECA AB |
Efficacy |
Approval |
05/02/2019 |
QTERNMET XR NDA #210874 |
ORIG-1 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
ASTRAZENECA AB |
Type 4 - New Combination |
Approval |
05/02/2019 |
TIBSOVO NDA #211192 |
SUPPL-1 |
IVOSIDENIB |
SERVIER |
Efficacy |
Approval |
05/03/2019 |
FELDENE NDA #018147 |
SUPPL-48 |
PIROXICAM |
PFIZER |
Labeling |
Approval |
05/03/2019 |
DAYPRO NDA #018841 |
SUPPL-30 |
OXAPROZIN |
PFIZER |
Labeling |
Approval |
05/03/2019 |
CIPRO NDA #019537 |
SUPPL-89 |
CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
CIPRO NDA #019847 |
SUPPL-60 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019857 |
SUPPL-69 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
LEVAQUIN NDA #020634 |
SUPPL-72 |
LEVOFLOXACIN |
JANSSEN PHARMS |
Labeling |
Approval |
05/03/2019 |
DAYPRO ALTA NDA #020776 |
SUPPL-8 |
OXAPROZIN POTASSIUM |
PFIZER |
Labeling |
Approval |
05/03/2019 |
CIPRO NDA #020780 |
SUPPL-46 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
CELEBREX NDA #020998 |
SUPPL-54 |
CELECOXIB |
UPJOHN |
Labeling |
Approval |
05/03/2019 |
AVELOX NDA #021085 |
SUPPL-65 |
MOXIFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
FACTIVE NDA #021158 |
SUPPL-26 |
GEMIFLOXACIN MESYLATE |
LG CHEM LTD |
Labeling |
Approval |
05/03/2019 |
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER NDA #021277 |
SUPPL-61 |
MOXIFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
CIPRO XR NDA #021473 |
SUPPL-40 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
05/03/2019 |
VANCOMYCIN HYDROCHLORIDE ANDA #065490 |
SUPPL-10 |
VANCOMYCIN HYDROCHLORIDE |
STRIDES PHARMA |
Manufacturing (CMC) |
Approval |
05/03/2019 |
OFLOXACIN ANDA #076182 |
SUPPL-18 |
OFLOXACIN |
TEVA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #076276 |
SUPPL-8 |
LEVOFLOXACIN |
NATCO PHARMA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #076361 |
SUPPL-13 |
LEVOFLOXACIN |
TEVA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #076710 |
SUPPL-14 |
LEVOFLOXACIN |
DR REDDYS LABS INC |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN ANDA #076717 |
SUPPL-7 |
CIPROFLOXACIN |
HIKMA FARMACEUTICA |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN IN DEXTROSE 5% ANDA #076757 |
SUPPL-9 |
CIPROFLOXACIN |
HIKMA FARMACEUTICA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #077097 |
SUPPL-8 |
LEVOFLOXACIN |
NATCO PHARMA |
Labeling |
Approval |
05/03/2019 |
OFLOXACIN ANDA #077098 |
SUPPL-12 |
OFLOXACIN |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN ANDA #077245 |
SUPPL-23 |
CIPROFLOXACIN |
HOSPIRA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #077438 |
SUPPL-17 |
LEVOFLOXACIN |
SANDOZ |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #077652 |
SUPPL-16 |
LEVOFLOXACIN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN EXTENDED RELEASE ANDA #077701 |
SUPPL-15 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN EXTENDED RELEASE ANDA #077701 |
SUPPL-16 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #077753 |
SUPPL-20 |
CIPROFLOXACIN |
HOSPIRA |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN ANDA #077782 |
SUPPL-20 |
CIPROFLOXACIN |
DR REDDYS |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN EXTENDED RELEASE ANDA #078166 |
SUPPL-14 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN EXTENDED RELEASE ANDA #078183 |
SUPPL-21 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
RISING PHARMA |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252 |
SUPPL-32 |
CIPROFLOXACIN |
INFORLIFE |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #078424 |
SUPPL-18 |
LEVOFLOXACIN |
LUPIN |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078431 |
SUPPL-10 |
CIPROFLOXACIN |
HIKMA FARMACEUTICA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078579 |
SUPPL-6 |
LEVOFLOXACIN |
HOSPIRA |
Labeling |
Approval |
05/03/2019 |
CIPROFLOXACIN EXTENDED RELEASE ANDA #078712 |
SUPPL-6 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
FOSUN PHARMA |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #078759 |
SUPPL-3 |
GEMCITABINE HYDROCHLORIDE |
TEYRO LABS |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #078759 |
SUPPL-4 |
GEMCITABINE HYDROCHLORIDE |
TEYRO LABS |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #078759 |
SUPPL-5 |
GEMCITABINE HYDROCHLORIDE |
TEYRO LABS |
Labeling |
Approval |
05/03/2019 |
ROCURONIUM BROMIDE ANDA #079195 |
SUPPL-17 |
ROCURONIUM BROMIDE |
SANDOZ |
Labeling |
Approval |
05/03/2019 |
OGEN .625 ANDA #083220 |
SUPPL-44 |
ESTROPIPATE |
PFIZER |
Labeling |
Approval |
05/03/2019 |
OGEN 1.25 ANDA #083220 |
SUPPL-44 |
ESTROPIPATE |
PFIZER |
Labeling |
Approval |
05/03/2019 |
OGEN 2.5 ANDA #083220 |
SUPPL-44 |
ESTROPIPATE |
PFIZER |
Labeling |
Approval |
05/03/2019 |
OGEN 5 ANDA #083220 |
SUPPL-44 |
ESTROPIPATE |
PFIZER |
Labeling |
Approval |
05/03/2019 |
DEPO-ESTRADIOL ANDA #085470 |
SUPPL-23 |
ESTRADIOL CYPIONATE |
PFIZER |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343 |
SUPPL-27 |
LEVOFLOXACIN |
INFORLIFE |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #090367 |
SUPPL-4 |
LEVOFLOXACIN |
CELLTRION |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #090722 |
SUPPL-14 |
LEVOFLOXACIN |
TORRENT PHARMS |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375 |
SUPPL-15 |
LEVOFLOXACIN |
HIKMA FARMACEUTICA |
Labeling |
Approval |
05/03/2019 |
KADCYLA BLA #125427 |
SUPPL-105 |
ADO-TRASTUZUMAB EMTANSINE |
GENENTECH |
|
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #200145 |
SUPPL-10 |
GEMCITABINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #200145 |
SUPPL-11 |
GEMCITABINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200250 |
SUPPL-4 |
LEVOFLOXACIN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200560 |
SUPPL-13 |
LEVOFLOXACIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #200674 |
SUPPL-8 |
LEVOFLOXACIN |
FRESENIUS KABI USA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200839 |
SUPPL-12 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200839 |
SUPPL-13 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200839 |
SUPPL-17 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200839 |
SUPPL-18 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #200839 |
SUPPL-19 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
05/03/2019 |
METOPROLOL TARTRATE ANDA #200981 |
SUPPL-14 |
METOPROLOL TARTRATE |
RUBICON |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #202200 |
SUPPL-8 |
LEVOFLOXACIN |
ORBION PHARMS |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #202328 |
SUPPL-10 |
LEVOFLOXACIN |
EUGIA PHARMA |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #202590 |
SUPPL-10 |
LEVOFLOXACIN |
AVET LIFESCIENCES |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #202801 |
SUPPL-5 |
LEVOFLOXACIN |
HETERO LABS LTD V |
Labeling |
Approval |
05/03/2019 |
OMEPRAZOLE ANDA #203270 |
SUPPL-10 |
OMEPRAZOLE |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #203613 |
SUPPL-4 |
LEVOFLOXACIN |
JUBILANT GENERICS |
Labeling |
Approval |
05/03/2019 |
FYREMADEL ANDA #204246 |
SUPPL-1 |
GANIRELIX ACETATE |
SUN PHARM |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #204549 |
SUPPL-2 |
GEMCITABINE HYDROCHLORIDE |
ACTAVIS INC |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #205242 |
SUPPL-1 |
GEMCITABINE HYDROCHLORIDE |
MYLAN LABS LTD |
Labeling |
Approval |
05/03/2019 |
TRIUMEQ NDA #205551 |
SUPPL-16 |
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
05/03/2019 |
MOXIFLOXACIN HYDROCHLORIDE NDA #205572 |
SUPPL-6 |
MOXIFLOXACIN HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
05/03/2019 |
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER ANDA #205833 |
SUPPL-5 |
MOXIFLOXACIN HYDROCHLORIDE |
MYLAN LABS LTD |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN ANDA #205968 |
SUPPL-3 |
LEVOFLOXACIN |
ZYDUS PHARMS |
Labeling |
Approval |
05/03/2019 |
ROCURONIUM BROMIDE ANDA #206206 |
SUPPL-3 |
ROCURONIUM BROMIDE |
EUGIA PHARMA |
Labeling |
Approval |
05/03/2019 |
QUETIAPINE FUMARATE ANDA #206260 |
SUPPL-2 |
QUETIAPINE FUMARATE |
PHARMADAX INC |
Labeling |
Approval |
05/03/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #206776 |
SUPPL-2 |
GEMCITABINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
05/03/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #206919 |
SUPPL-5 |
LEVOFLOXACIN |
EUGIA PHARMA |
Labeling |
Approval |
05/03/2019 |
MELPHALAN HYDROCHLORIDE ANDA #207032 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
USWM |
|
Approval |
05/03/2019 |
BAXDELA NDA #208610 |
SUPPL-6 |
DELAFLOXACIN MEGLUMINE |
MELINTA |
Labeling |
Approval |
05/03/2019 |
BAXDELA NDA #208611 |
SUPPL-5 |
DELAFLOXACIN MEGLUMINE |
MELINTA |
Labeling |
Approval |
05/03/2019 |
FENTANYL CITRATE PRESERVATIVE FREE ANDA #210762 |
ORIG-1 |
FENTANYL CITRATE |
FRESENIUS KABI USA |
|
Approval |
05/03/2019 |
VYNDAQEL NDA #211996 |
ORIG-1 |
TAFAMIDIS MEGLUMINE |
FOLDRX PHARMS |
Type 1 - New Molecular Entity |
Approval |
05/03/2019 |
VYNDAMAX NDA #212161 |
ORIG-1 |
TAFAMIDIS |
FOLDRX PHARMS |
Type 2 - New Active Ingredient |
Approval |
05/03/2019 |
FUROSEMIDE ANDA #212174 |
ORIG-1 |
FUROSEMIDE |
EUGIA PHARMA |
|
Approval |
05/06/2019 |
SORILUX NDA #022563 |
SUPPL-6 |
CALCIPOTRIENE |
MAYNE PHARMA |
Efficacy |
Approval |
05/06/2019 |
CIPROFLOXACIN EXTENDED RELEASE ANDA #077809 |
SUPPL-8 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
05/06/2019 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078024 |
SUPPL-29 |
CIPROFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078024 |
SUPPL-30 |
CIPROFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
CIPROFLOXACIN ANDA #078062 |
SUPPL-17 |
CIPROFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
CIPROFLOXACIN ANDA #078062 |
SUPPL-18 |
CIPROFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 1 ANDA #085055 |
SUPPL-56 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 1 ANDA #085055 |
SUPPL-62 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 2 ANDA #085055 |
SUPPL-56 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 2 ANDA #085055 |
SUPPL-62 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 3 ANDA #085055 |
SUPPL-56 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 3 ANDA #085055 |
SUPPL-62 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 4 ANDA #085055 |
SUPPL-56 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
TYLENOL W/ CODEINE NO. 4 ANDA #085055 |
SUPPL-62 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
05/06/2019 |
LEVOFLOXACIN ANDA #090787 |
SUPPL-10 |
LEVOFLOXACIN |
APOTEX INC |
Labeling |
Approval |
05/06/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091397 |
SUPPL-18 |
LEVOFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091397 |
SUPPL-19 |
LEVOFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
LEVOFLOXACIN ANDA #091436 |
SUPPL-9 |
LEVOFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
LEVOFLOXACIN ANDA #091436 |
SUPPL-10 |
LEVOFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/06/2019 |
ENTYVIO BLA #125476 |
SUPPL-27 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
05/06/2019 |
LEVOFLOXACIN ANDA #201043 |
SUPPL-18 |
LEVOFLOXACIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
05/06/2019 |
DICLOFENAC SODIUM ANDA #204306 |
ORIG-1 |
DICLOFENAC SODIUM |
AUROLIFE PHARMA LLC |
|
Approval |
05/06/2019 |
LITHIUM CARBONATE ANDA #205532 |
SUPPL-2 |
LITHIUM CARBONATE |
HERITAGE PHARMA |
Manufacturing (CMC) |
Approval |
05/06/2019 |
RUZURGI NDA #209321 |
ORIG-2 |
AMIFAMPRIDINE |
JACOBUS PHARM CO INC |
Efficacy |
Tentative Approval |
05/06/2019 |
ARSENIC TRIOXIDE ANDA #209873 |
ORIG-1 |
ARSENIC TRIOXIDE |
PENN LIFE |
|
Approval |
05/06/2019 |
COLESEVELAM HYDROCHLORIDE ANDA #210316 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
05/06/2019 |
ONPATTRO NDA #210922 |
SUPPL-1 |
PATISIRAN SODIUM |
ALNYLAM PHARMS INC |
Labeling |
Approval |
05/06/2019 |
POTASSIUM CHLORIDE ANDA #212183 |
ORIG-1 |
POTASSIUM CHLORIDE |
BELCHER |
|
Approval |
05/06/2019 |
TECENTRIQ BLA #761034 |
SUPPL-13 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
05/06/2019 |
TECENTRIQ BLA #761034 |
SUPPL-14 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
05/07/2019 |
NAVELBINE NDA #020388 |
SUPPL-36 |
VINORELBINE TARTRATE |
PIERRE FABRE |
Labeling |
Approval |
05/07/2019 |
CLARITIN HIVES RELIEF REDITAB NDA #020704 |
SUPPL-35 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
05/07/2019 |
CLARITIN REDITABS NDA #020704 |
SUPPL-35 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
05/07/2019 |
SUTENT NDA #021938 |
SUPPL-36 |
SUNITINIB MALATE |
CPPI CV |
Efficacy |
Approval |
05/07/2019 |
LEVOFLOXACIN ANDA #076890 |
SUPPL-15 |
LEVOFLOXACIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
05/07/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #091351 |
SUPPL-2 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
LUPIN LTD |
Labeling |
Approval |
05/07/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #091351 |
SUPPL-4 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
LUPIN LTD |
Labeling |
Approval |
05/07/2019 |
LOSARTAN POTASSIUM ANDA #091541 |
SUPPL-12 |
LOSARTAN POTASSIUM |
MICRO LABS |
Labeling |
Approval |
05/07/2019 |
ENTYVIO BLA #125476 |
SUPPL-24 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
05/07/2019 |
TELMISARTAN AND AMLODIPINE ANDA #201586 |
SUPPL-6 |
AMLODIPINE BESYLATE; TELMISARTAN |
LUPIN LTD |
Labeling |
Approval |
05/07/2019 |
LOSARTAN POTASSIUM ANDA #203030 |
SUPPL-4 |
LOSARTAN POTASSIUM |
UNICHEM |
Labeling |
Approval |
05/07/2019 |
DESVENLAFAXINE SUCCINATE ANDA #204805 |
ORIG-1 |
DESVENLAFAXINE SUCCINATE |
INTELLIPHARMACEUTICS |
|
Approval |
05/07/2019 |
ROSUVASTATIN CALCIUM ANDA #207375 |
ORIG-1 |
ROSUVASTATIN CALCIUM |
SHANDONG |
|
Approval |
05/07/2019 |
LUXZYLA ANDA #209921 |
ORIG-1 |
PENICILLAMINE |
ANI PHARMS |
|
Approval |
05/07/2019 |
BUSULFAN ANDA #210448 |
ORIG-1 |
BUSULFAN |
APOTEX |
|
Approval |
05/08/2019 |
DECADRON NDA #011664 |
SUPPL-64 |
DEXAMETHASONE |
MERCK |
Labeling |
Approval |
05/08/2019 |
LO/OVRAL-28 NDA #017802 |
SUPPL-34 |
ETHINYL ESTRADIOL; NORGESTREL |
WYETH PHARMS |
Labeling |
Approval |
05/08/2019 |
NORMINEST FE NDA #017948 |
SUPPL-46 |
ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE |
GD SEARLE LLC |
Labeling |
Approval |
05/08/2019 |
NORQUEST FE NDA #018926 |
SUPPL-13 |
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE |
PFIZER |
Labeling |
Approval |
05/08/2019 |
TRIPHASIL-28 NDA #019190 |
SUPPL-49 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WYETH PHARMS INC |
Labeling |
Approval |
05/08/2019 |
TRIPHASIL-21 NDA #019192 |
SUPPL-48 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WYETH PHARMS |
Labeling |
Approval |
05/08/2019 |
NUVARING NDA #021187 |
SUPPL-37 |
ETHINYL ESTRADIOL; ETONOGESTREL |
ORGANON USA ORGANON |
Labeling |
Approval |
05/08/2019 |
OMNARIS NDA #022004 |
SUPPL-18 |
CICLESONIDE |
COVIS |
Labeling |
Approval |
05/08/2019 |
BETHANECHOL CHLORIDE ANDA #040728 |
SUPPL-2 |
BETHANECHOL CHLORIDE |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
05/08/2019 |
PROLIA BLA #125320 |
SUPPL-196 |
DENOSUMAB |
AMGEN |
|
Approval |
05/08/2019 |
PROLIA BLA #125320 |
SUPPL-199 |
DENOSUMAB |
AMGEN |
|
Approval |
05/08/2019 |
XGEVA BLA #125320 |
SUPPL-196 |
DENOSUMAB |
AMGEN |
|
Approval |
05/08/2019 |
XGEVA BLA #125320 |
SUPPL-199 |
DENOSUMAB |
AMGEN |
|
Approval |
05/08/2019 |
YERVOY BLA #125377 |
SUPPL-102 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
05/08/2019 |
ESZOPICLONE ANDA #203087 |
ORIG-1 |
ESZOPICLONE |
NOSTRUM LABS INC |
|
Approval |
05/08/2019 |
BUSULFAN ANDA #207050 |
SUPPL-1 |
BUSULFAN |
PHARMASCIENCE INC |
Labeling |
Approval |
05/08/2019 |
BUSULFAN ANDA #207050 |
SUPPL-2 |
BUSULFAN |
PHARMASCIENCE INC |
Labeling |
Approval |
05/08/2019 |
DAPSONE ANDA #207165 |
ORIG-1 |
DAPSONE |
RISING PHARMA |
|
Approval |
05/09/2019 |
CREON BLA #020725 |
SUPPL-25 |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
ABBVIE |
|
Approval |
05/09/2019 |
LANTUS BLA #021081 |
SUPPL-72 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
05/09/2019 |
LANTUS SOLOSTAR BLA #021081 |
SUPPL-72 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
05/09/2019 |
XYREM NDA #021196 |
SUPPL-31 |
SODIUM OXYBATE |
JAZZ PHARMS |
Labeling |
Approval |
05/09/2019 |
ARMODAFINIL ANDA #200043 |
ORIG-2 |
ARMODAFINIL |
MYLAN PHARMS INC |
|
Approval |
05/09/2019 |
MESALAMINE ANDA #207873 |
ORIG-1 |
MESALAMINE |
TEVA PHARMS USA |
|
Approval |
05/09/2019 |
HYDROXYPROGESTERONE CAPROATE ANDA #211142 |
ORIG-1 |
HYDROXYPROGESTERONE CAPROATE |
EUGIA PHARMA |
|
Approval |
05/09/2019 |
SPRAVATO NDA #211243 |
SUPPL-1 |
ESKETAMINE HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
05/10/2019 |
ANAFRANIL NDA #019906 |
SUPPL-43 |
CLOMIPRAMINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
05/10/2019 |
EPIVIR NDA #020564 |
SUPPL-39 |
LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
05/10/2019 |
EPIVIR NDA #020596 |
SUPPL-38 |
LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
05/10/2019 |
COMBIVIR NDA #020857 |
SUPPL-34 |
LAMIVUDINE; ZIDOVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
05/10/2019 |
ANDROGEL NDA #021015 |
SUPPL-45 |
TESTOSTERONE |
BESINS HLTHCARE |
Labeling |
Approval |
05/10/2019 |
TRIZIVIR NDA #021205 |
SUPPL-38 |
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
05/10/2019 |
TESTIM NDA #021454 |
SUPPL-27 |
TESTOSTERONE |
ENDO OPERATIONS |
Labeling |
Approval |
05/10/2019 |
FORTESTA NDA #021463 |
SUPPL-20 |
TESTOSTERONE |
ENDO OPERATIONS |
Labeling |
Approval |
05/10/2019 |
CADUET NDA #021540 |
SUPPL-44 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
PHARMACIA |
Labeling |
Approval |
05/10/2019 |
EPZICOM NDA #021652 |
SUPPL-24 |
ABACAVIR SULFATE; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
05/10/2019 |
ANDROGEL NDA #022309 |
SUPPL-20 |
TESTOSTERONE |
BESINS HLTHCARE |
Labeling |
Approval |
05/10/2019 |
ZOSYN NDA #050684 |
SUPPL-94 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WYETH PHARMS |
Labeling |
Approval |
05/10/2019 |
ZOSYN IN PLASTIC CONTAINER NDA #050750 |
SUPPL-41 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-8 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-12 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-13 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-14 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-16 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/10/2019 |
Xeomin BLA #125360 |
SUPPL-74 |
incobotulinumtoxinA |
MERZ PHARMS |
|
Approval |
05/10/2019 |
CYRAMZA BLA #125477 |
SUPPL-29 |
RAMUCIRUMAB |
ELI LILLY AND CO |
|
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #202176 |
SUPPL-7 |
LANSOPRAZOLE |
WOCKHARDT |
Labeling |
Approval |
05/10/2019 |
LANSOPRAZOLE ANDA #202176 |
SUPPL-8 |
LANSOPRAZOLE |
WOCKHARDT |
Labeling |
Approval |
05/10/2019 |
TESTOSTERONE ANDA #204255 |
SUPPL-4 |
TESTOSTERONE |
PADAGIS ISRAEL |
Labeling |
Approval |
05/10/2019 |
VOGELXO NDA #204399 |
SUPPL-10 |
TESTOSTERONE |
UPSHER SMITH LABS |
Labeling |
Approval |
05/10/2019 |
TESTOSTERONE ANDA #205328 |
SUPPL-1 |
TESTOSTERONE |
ACTAVIS LABS UT INC |
Labeling |
Approval |
05/10/2019 |
SAPROPTERIN DIHYDROCHLORIDE ANDA #207200 |
ORIG-1 |
SAPROPTERIN DIHYDROCHLORIDE |
ENDO OPERATIONS |
|
Approval |
05/10/2019 |
NUPLAZID NDA #207318 |
SUPPL-7 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
05/10/2019 |
CHLORTHALIDONE ANDA #207813 |
ORIG-1 |
CHLORTHALIDONE |
ZYDUS PHARMS |
|
Approval |
05/10/2019 |
TESTOSTERONE ANDA #208061 |
SUPPL-1 |
TESTOSTERONE |
LUPIN LTD |
Labeling |
Approval |
05/10/2019 |
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE ANDA #208499 |
ORIG-1 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
PERRIGO R AND D |
|
Approval |
05/10/2019 |
ESOMEPRAZOLE MAGNESIUM ANDA #209495 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
GLENMARK SPECLT |
|
Approval |
05/10/2019 |
TESTOSTERONE ANDA #209533 |
SUPPL-3 |
TESTOSTERONE |
CIPLA |
Labeling |
Approval |
05/10/2019 |
NUPLAZID NDA #210793 |
SUPPL-2 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
05/10/2019 |
DEXAMETHASONE SODIUM PHOSPHATE ANDA #211036 |
ORIG-1 |
DEXAMETHASONE SODIUM PHOSPHATE |
SOMERSET THERAPS LLC |
|
Approval |
05/10/2019 |
OXYBUTYNIN CHLORIDE ANDA #211682 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
AVET LIFESCIENCES |
|
Approval |
05/10/2019 |
OXYBUTYNIN CHLORIDE ANDA #211682 |
SUPPL-1 |
OXYBUTYNIN CHLORIDE |
AVET LIFESCIENCES |
|
Approval |
05/13/2019 |
ALEVE NDA #020204 |
SUPPL-63 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
05/13/2019 |
ALEVE NDA #020204 |
SUPPL-64 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
05/13/2019 |
ALEVE NDA #020204 |
SUPPL-65 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
05/13/2019 |
EYLEA BLA #125387 |
SUPPL-61 |
AFLIBERCEPT |
REGENERON PHARMACEUTICALS |
|
Approval |
05/13/2019 |
ENTECAVIR ANDA #202122 |
SUPPL-3 |
ENTECAVIR |
TEVA PHARMS USA |
Labeling |
Approval |
05/13/2019 |
ENTECAVIR ANDA #202122 |
SUPPL-5 |
ENTECAVIR |
TEVA PHARMS USA |
Labeling |
Approval |
05/13/2019 |
ENTECAVIR ANDA #202122 |
SUPPL-7 |
ENTECAVIR |
TEVA PHARMS USA |
Labeling |
Approval |
05/13/2019 |
ODOMZO NDA #205266 |
SUPPL-6 |
SONIDEGIB PHOSPHATE |
SUN PHARM |
Labeling |
Approval |
05/13/2019 |
RISEDRONATE SODIUM ANDA #205280 |
ORIG-1 |
RISEDRONATE SODIUM |
ORBION PHARMS |
|
Approval |
05/13/2019 |
DOXORUBICIN HYDROCHLORIDE ANDA #206062 |
ORIG-1 |
DOXORUBICIN HYDROCHLORIDE |
HISUN PHARM HANGZHOU |
|
Approval |
05/13/2019 |
CORLANOR NDA #206143 |
SUPPL-7 |
IVABRADINE HYDROCHLORIDE |
AMGEN INC |
Labeling |
Approval |
05/13/2019 |
ENTECAVIR ANDA #206872 |
SUPPL-2 |
ENTECAVIR |
CIPLA |
Labeling |
Approval |
05/13/2019 |
ENTECAVIR ANDA #206872 |
SUPPL-3 |
ENTECAVIR |
CIPLA |
Labeling |
Approval |
05/13/2019 |
ENTECAVIR ANDA #208721 |
SUPPL-1 |
ENTECAVIR |
BRECKENRIDGE |
Labeling |
Approval |
05/13/2019 |
FENOFIBRATE (MICRONIZED) ANDA #209504 |
SUPPL-2 |
FENOFIBRATE |
ANI PHARMS |
Labeling |
Approval |
05/13/2019 |
LABETALOL HYDROCHLORIDE ANDA #211325 |
ORIG-1 |
LABETALOL HYDROCHLORIDE |
CADILA PHARMS LTD |
|
Approval |
05/13/2019 |
NEOSTIGMINE METHYLSULFATE ANDA #212512 |
ORIG-1 |
NEOSTIGMINE METHYLSULFATE |
BE PHARMS |
|
Approval |
05/14/2019 |
GEMZAR NDA #020509 |
SUPPL-82 |
GEMCITABINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
05/14/2019 |
EDURANT NDA #202022 |
SUPPL-13 |
RILPIVIRINE HYDROCHLORIDE |
JANSSEN PRODS |
Labeling |
Approval |
05/14/2019 |
VASOSTRICT NDA #204485 |
SUPPL-9 |
VASOPRESSIN |
ENDO OPERATIONS |
Labeling |
Approval |
05/14/2019 |
FULVESTRANT ANDA #205935 |
ORIG-1 |
FULVESTRANT |
SANDOZ |
|
Approval |
05/14/2019 |
ALBENDAZOLE ANDA #211117 |
ORIG-1 |
ALBENDAZOLE |
EDENBRIDGE PHARMS |
|
Approval |
05/14/2019 |
GLYCOPYRROLATE ANDA #211334 |
ORIG-1 |
GLYCOPYRROLATE |
SANDOZ |
|
Approval |
05/14/2019 |
BAVENCIO BLA #761049 |
SUPPL-6 |
AVELUMAB |
EMD SERONO INC |
|
Approval |
05/15/2019 |
TRIGLIDE NDA #021350 |
SUPPL-22 |
FENOFIBRATE |
SKYEPHARMA AG |
Labeling |
Approval |
05/15/2019 |
LIPOFEN NDA #021612 |
SUPPL-20 |
FENOFIBRATE |
CIPHER PHARMS INC |
Labeling |
Approval |
05/15/2019 |
ANTARA (MICRONIZED) NDA #021695 |
SUPPL-20 |
FENOFIBRATE |
LUPIN |
Labeling |
Approval |
05/15/2019 |
FENOGLIDE NDA #022118 |
SUPPL-10 |
FENOFIBRATE |
SALIX |
Labeling |
Approval |
05/15/2019 |
FIBRICOR NDA #022418 |
SUPPL-15 |
FENOFIBRIC ACID |
ATHENA |
Labeling |
Approval |
05/15/2019 |
ALLOPURINOL ANDA #071450 |
SUPPL-40 |
ALLOPURINOL |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #075753 |
SUPPL-10 |
FENOFIBRATE |
RHODES PHARMS |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #075868 |
SUPPL-20 |
FENOFIBRATE |
IMPAX LABS |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #202676 |
SUPPL-5 |
FENOFIBRATE |
RISING |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #205566 |
SUPPL-3 |
FENOFIBRATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #207378 |
SUPPL-4 |
FENOFIBRATE |
INVAGEN PHARMS |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #207805 |
SUPPL-8 |
FENOFIBRATE |
REYOUNG |
Labeling |
Approval |
05/15/2019 |
ZOLEDRONIC ACID ANDA #208513 |
ORIG-1 |
ZOLEDRONIC ACID |
SHILPA |
|
Approval |
05/15/2019 |
VENCLEXTA NDA #208573 |
SUPPL-13 |
VENETOCLAX |
ABBVIE |
Efficacy |
Approval |
05/15/2019 |
TRELEGY ELLIPTA NDA #209482 |
SUPPL-5 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #209504 |
SUPPL-4 |
FENOFIBRATE |
ANI PHARMS |
Labeling |
Approval |
05/15/2019 |
IBUPROFEN ANDA #210149 |
SUPPL-1 |
IBUPROFEN |
GUARDIAN DRUG |
Manufacturing (CMC) |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #210705 |
SUPPL-1 |
FENOFIBRATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
05/15/2019 |
FENOFIBRATE (MICRONIZED) ANDA #210782 |
SUPPL-1 |
FENOFIBRATE |
TORRENT |
Labeling |
Approval |
05/16/2019 |
FRAGMIN NDA #020287 |
SUPPL-72 |
DALTEPARIN SODIUM |
PFIZER |
Efficacy |
Approval |
05/16/2019 |
AGGRASTAT NDA #020912 |
SUPPL-27 |
TIROFIBAN HYDROCHLORIDE |
MEDICURE |
Labeling |
Approval |
05/16/2019 |
AGGRASTAT NDA #020913 |
SUPPL-26 |
TIROFIBAN HYDROCHLORIDE |
MEDICURE |
Labeling |
Approval |
05/16/2019 |
TRACLEER NDA #021290 |
SUPPL-39 |
BOSENTAN |
ACTELION |
Labeling |
Approval |
05/16/2019 |
LIVALO NDA #022363 |
SUPPL-15 |
PITAVASTATIN CALCIUM |
KOWA CO |
Efficacy |
Approval |
05/16/2019 |
GATTEX KIT NDA #203441 |
SUPPL-13 |
TEDUGLUTIDE |
TAKEDA PHARMS USA |
Efficacy |
Approval |
05/16/2019 |
TESTOSTERONE ANDA #204570 |
SUPPL-1 |
TESTOSTERONE |
ACTAVIS LABS UT INC |
Labeling |
Approval |
05/16/2019 |
TRACLEER NDA #209279 |
SUPPL-5 |
BOSENTAN |
ACTELION |
Labeling |
Approval |
05/16/2019 |
JORNAY PM NDA #209311 |
SUPPL-3 |
METHYLPHENIDATE HYDROCHLORIDE |
IRONSHORE PHARMS |
Labeling |
Approval |
05/16/2019 |
DOCETAXEL ANDA #210327 |
ORIG-1 |
DOCETAXEL |
SHILPA |
|
Approval |
05/16/2019 |
DOLUTEGRAVIR SODIUM ANDA #210963 |
ORIG-1 |
DOLUTEGRAVIR SODIUM |
LAURUS LABS LTD |
|
Tentative Approval |
05/16/2019 |
DICLOFENAC SODIUM ANDA #211253 |
ORIG-1 |
DICLOFENAC SODIUM |
PERRIGO PHARMA INTL |
|
Approval |
05/16/2019 |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ANDA #212266 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE |
QUAGEN |
|
Approval |
05/16/2019 |
HERZUMA BLA #761091 |
SUPPL-1 |
TRASTUZUMAB-PKRB |
CELLTRION INC |
|
Approval |
05/16/2019 |
HERZUMA BLA #761091 |
SUPPL-2 |
TRASTUZUMAB-PKRB |
CELLTRION INC |
|
Approval |
05/17/2019 |
PLAVIX NDA #020839 |
SUPPL-72 |
CLOPIDOGREL BISULFATE |
SANOFI AVENTIS US |
Labeling |
Approval |
05/17/2019 |
ORFADIN NDA #021232 |
SUPPL-23 |
NITISINONE |
SWEDISH ORPHAN |
Labeling |
Approval |
05/17/2019 |
SUMATRIPTAN SUCCINATE ANDA #078295 |
SUPPL-8 |
SUMATRIPTAN SUCCINATE |
SUN PHARM INDS |
Labeling |
Approval |
05/17/2019 |
SUMATRIPTAN SUCCINATE ANDA #078327 |
SUPPL-11 |
SUMATRIPTAN SUCCINATE |
AUROBINDO PHARMA |
Labeling |
Approval |
05/17/2019 |
IMIPENEM AND CILASTATIN ANDA #090825 |
SUPPL-11 |
CILASTATIN SODIUM; IMIPENEM |
HOSPIRA INC |
Labeling |
Approval |
05/17/2019 |
IMIPENEM AND CILASTATIN ANDA #090825 |
SUPPL-12 |
CILASTATIN SODIUM; IMIPENEM |
HOSPIRA INC |
Labeling |
Approval |
05/17/2019 |
AZELASTINE HYDROCHLORIDE ANDA #091444 |
SUPPL-3 |
AZELASTINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
05/17/2019 |
PROLEUKIN BLA #103293 |
SUPPL-5146 |
ALDESLEUKIN |
CHIRON |
|
Approval |
05/17/2019 |
TELMISARTAN ANDA #202397 |
SUPPL-6 |
TELMISARTAN |
MYLAN |
Labeling |
Approval |
05/17/2019 |
TELMISARTAN ANDA #203867 |
SUPPL-7 |
TELMISARTAN |
SANDOZ |
Labeling |
Approval |
05/17/2019 |
MELPHALAN HYDROCHLORIDE ANDA #204817 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
ALMAJECT |
|
Approval |
05/17/2019 |
ORFADIN NDA #206356 |
SUPPL-6 |
NITISINONE |
SWEDISH ORPHAN |
Labeling |
Approval |
05/17/2019 |
MICAFUNGIN SODIUM ANDA #207344 |
ORIG-1 |
MICAFUNGIN SODIUM |
FRESENIUS KABI USA |
|
Approval |
05/17/2019 |
AZELASTINE HYDROCHLORIDE ANDA #207610 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
EPIC PHARMA LLC |
|
Approval |
05/17/2019 |
LURASIDONE HYDROCHLORIDE ANDA #208060 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
TEVA PHARMS USA |
|
Approval |
05/17/2019 |
TELMISARTAN ANDA #208605 |
SUPPL-1 |
TELMISARTAN |
CADILA PHARMS LTD |
Labeling |
Approval |
05/17/2019 |
CINACALCET HYDROCHLORIDE ANDA #210570 |
ORIG-1 |
CINACALCET HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
05/17/2019 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #210651 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
RHODES PHARMS |
|
Approval |
05/17/2019 |
NAYZILAM NDA #211321 |
ORIG-1 |
MIDAZOLAM |
UCB INC |
Type 3 - New Dosage Form |
Approval |
05/17/2019 |
ZULRESSO NDA #211371 |
SUPPL-1 |
BREXANOLONE |
SAGE THERAP |
REMS |
Approval |
05/17/2019 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #211715 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
|
Approval |
05/18/2019 |
HEPARIN SODIUM NDA #017037 |
SUPPL-183 |
HEPARIN SODIUM |
HIKMA |
Manufacturing (CMC) |
Approval |
05/19/2019 |
MOMETASONE FUROATE ANDA #076624 |
SUPPL-8 |
MOMETASONE FUROATE |
TARO |
Labeling |
Approval |
05/19/2019 |
BENAZEPRIL HYDROCHLORIDE ANDA #076820 |
SUPPL-18 |
BENAZEPRIL HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
05/19/2019 |
LETROZOLE ANDA #090289 |
SUPPL-4 |
LETROZOLE |
TEVA PHARMS |
Labeling |
Approval |
05/19/2019 |
LETROZOLE ANDA #090289 |
SUPPL-5 |
LETROZOLE |
TEVA PHARMS |
Labeling |
Approval |
05/19/2019 |
LETROZOLE ANDA #091303 |
SUPPL-2 |
LETROZOLE |
APOTEX INC |
Labeling |
Approval |
05/19/2019 |
LETROZOLE ANDA #091303 |
SUPPL-3 |
LETROZOLE |
APOTEX INC |
Labeling |
Approval |
05/19/2019 |
LETROZOLE ANDA #202716 |
SUPPL-2 |
LETROZOLE |
CHARTWELL RX |
Labeling |
Approval |
05/19/2019 |
LETROZOLE ANDA #202716 |
SUPPL-3 |
LETROZOLE |
CHARTWELL RX |
Labeling |
Approval |
05/20/2019 |
APOKYN NDA #021264 |
SUPPL-16 |
APOMORPHINE HYDROCHLORIDE |
MDD US |
Labeling |
Approval |
05/20/2019 |
FASLODEX NDA #021344 |
SUPPL-39 |
FULVESTRANT |
ASTRAZENECA |
Labeling |
Approval |
05/20/2019 |
PEMETREXED ANDA #090352 |
ORIG-1 |
PEMETREXED SODIUM |
TEVA PHARMS USA |
|
Tentative Approval |
05/20/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #090686 |
SUPPL-12 |
DONEPEZIL HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #202551 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
WATSON LABS INC |
|
Approval |
05/20/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #203656 |
SUPPL-1 |
DONEPEZIL HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
05/20/2019 |
DACTINOMYCIN ANDA #203999 |
ORIG-1 |
DACTINOMYCIN |
XGEN PHARMS |
|
Approval |
05/20/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #204609 |
SUPPL-2 |
DONEPEZIL HYDROCHLORIDE |
CADILA PHARMS LTD |
Labeling |
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #205483 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
AJANTA PHARMA LTD |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #205575 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
ALEMBIC |
|
Approval |
05/20/2019 |
ALBENDAZOLE ANDA #208094 |
ORIG-1 |
ALBENDAZOLE |
ACTAVIS ELIZABETH |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #209239 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
GLENMARK SPECLT |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #209333 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
QILU |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #209719 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
AMNEAL PHARMS CO |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #209818 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
BRECKENRIDGE |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #209839 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
CIPLA |
|
Approval |
05/20/2019 |
METHYLPREDNISOLONE ACETATE ANDA #210043 |
ORIG-1 |
METHYLPREDNISOLONE ACETATE |
AMNEAL |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #210224 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
ALKEM LABS LTD |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #210281 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
AUSTARPHARMA |
|
Approval |
05/20/2019 |
FULVESTRANT NDA #210326 |
ORIG-1 |
FULVESTRANT |
FRESENIUS KABI USA |
Type 5 - New Formulation or New Manufacturer |
Approval |
05/20/2019 |
DIMETHYL FUMARATE ANDA #210492 |
ORIG-1 |
DIMETHYL FUMARATE |
SUN PHARM INDS LTD |
|
Tentative Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #210582 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
CHARTWELL RX |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #210688 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
MSN |
|
Approval |
05/20/2019 |
SOLIFENACIN SUCCINATE ANDA #211657 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
SCIEGEN PHARMS INC |
|
Approval |
05/21/2019 |
WELCHOL NDA #021176 |
SUPPL-45 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
05/21/2019 |
WELCHOL NDA #022362 |
SUPPL-25 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
05/21/2019 |
CLEOCIN NDA #050680 |
SUPPL-17 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
05/21/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #077518 |
SUPPL-2 |
DONEPEZIL HYDROCHLORIDE |
CIPLA LTD |
Labeling |
Approval |
05/21/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #090056 |
SUPPL-10 |
DONEPEZIL HYDROCHLORIDE |
AUROBINDO |
Labeling |
Approval |
05/21/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #090290 |
SUPPL-9 |
DONEPEZIL HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
05/21/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #201724 |
SUPPL-5 |
DONEPEZIL HYDROCHLORIDE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
05/21/2019 |
LOSARTAN POTASSIUM ANDA #202230 |
SUPPL-10 |
LOSARTAN POTASSIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
05/21/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #202723 |
SUPPL-4 |
DONEPEZIL HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
05/21/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #202723 |
SUPPL-5 |
DONEPEZIL HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
05/21/2019 |
PARICALCITOL ANDA #206699 |
SUPPL-1 |
PARICALCITOL |
AMNEAL PHARMS CO |
Labeling |
Approval |
05/21/2019 |
DALFAMPRIDINE ANDA #208292 |
ORIG-1 |
DALFAMPRIDINE |
SUN PHARM |
|
Approval |
05/21/2019 |
YUPELRI NDA #210598 |
SUPPL-1 |
REVEFENACIN |
MYLAN IRELAND LTD |
Labeling |
Approval |
05/22/2019 |
SOTRADECOL ANDA #040541 |
SUPPL-15 |
SODIUM TETRADECYL SULFATE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
05/22/2019 |
OFLOXACIN ANDA #076093 |
SUPPL-11 |
OFLOXACIN |
LARKEN LABS |
Labeling |
Approval |
05/22/2019 |
SUMATRIPTAN SUCCINATE ANDA #090358 |
SUPPL-15 |
SUMATRIPTAN SUCCINATE |
SUN PHARM |
Labeling |
Approval |
05/22/2019 |
DULOXETINE HYDROCHLORIDE ANDA #090739 |
SUPPL-13 |
DULOXETINE HYDROCHLORIDE |
ZYDUS HLTHCARE |
Labeling |
Approval |
05/22/2019 |
LEVOFLOXACIN ANDA #091678 |
SUPPL-4 |
LEVOFLOXACIN |
NOVITIUM PHARMA |
Labeling |
Approval |
05/22/2019 |
DECITABINE NDA #205582 |
SUPPL-9 |
DECITABINE |
SUN PHARM |
Labeling |
Approval |
05/22/2019 |
ESOMEPRAZOLE MAGNESIUM ANDA #206296 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
ZYDUS PHARMS |
|
Approval |
05/22/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #206776 |
SUPPL-3 |
GEMCITABINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
05/22/2019 |
PHYTONADIONE ANDA #207719 |
ORIG-1 |
PHYTONADIONE |
DR REDDYS |
|
Approval |
05/22/2019 |
SIKLOS NDA #208843 |
SUPPL-2 |
HYDROXYUREA |
THERAVIA |
Labeling |
Approval |
05/22/2019 |
EPIDIOLEX NDA #210365 |
SUPPL-4 |
CANNABIDIOL |
JAZZ PHARMS RES |
Manufacturing (CMC) |
Approval |
05/22/2019 |
TRIENTINE HYDROCHLORIDE ANDA #211134 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
MSN |
|
Approval |
05/22/2019 |
CYPROHEPTADINE HYDROCHLORIDE ANDA #212423 |
ORIG-1 |
CYPROHEPTADINE HYDROCHLORIDE |
QUAGEN |
|
Approval |
05/23/2019 |
LYRICA NDA #021446 |
SUPPL-36 |
PREGABALIN |
UPJOHN |
Efficacy |
Approval |
05/23/2019 |
LYRICA NDA #022488 |
SUPPL-14 |
PREGABALIN |
UPJOHN |
Efficacy |
Approval |
05/23/2019 |
LEVOFLOXACIN ANDA #091678 |
SUPPL-6 |
LEVOFLOXACIN |
NOVITIUM PHARMA |
Labeling |
Approval |
05/23/2019 |
ENSKYCE ANDA #201887 |
SUPPL-8 |
DESOGESTREL; ETHINYL ESTRADIOL |
LUPIN LTD |
Labeling |
Approval |
05/23/2019 |
ENSKYCE ANDA #201887 |
SUPPL-10 |
DESOGESTREL; ETHINYL ESTRADIOL |
LUPIN LTD |
Labeling |
Approval |
05/23/2019 |
ENSKYCE ANDA #201887 |
SUPPL-13 |
DESOGESTREL; ETHINYL ESTRADIOL |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
05/23/2019 |
FLUOXETINE HYDROCHLORIDE ANDA #206993 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
CADILA PHARMS LTD |
|
Approval |
05/23/2019 |
PEMETREXED SODIUM ANDA #208262 |
ORIG-1 |
PEMETREXED SODIUM |
WOCKHARDT BIO AG |
|
Tentative Approval |
05/23/2019 |
POTASSIUM CHLORIDE ANDA #210902 |
ORIG-1 |
POTASSIUM CHLORIDE |
AMNEAL |
|
Approval |
05/23/2019 |
SLYND NDA #211367 |
ORIG-1 |
DROSPIRENONE |
EXELTIS USA INC |
Type 2 - New Active Ingredient and Type 3 - New Dosage Form |
Approval |
05/23/2019 |
METHYLPHENIDATE HYDROCHLORIDE ANDA #211796 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
GRANULES |
|
Approval |
05/23/2019 |
CLOBAZAM ANDA #212398 |
ORIG-1 |
CLOBAZAM |
ACCORD HLTHCARE |
|
Approval |
05/23/2019 |
TRUXIMA BLA #761088 |
SUPPL-1 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
05/23/2019 |
TRUXIMA BLA #761088 |
SUPPL-2 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
05/24/2019 |
ZAROXOLYN NDA #017386 |
SUPPL-43 |
METOLAZONE |
I3 PHARMS |
Manufacturing (CMC) |
Approval |
05/24/2019 |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020201 |
SUPPL-40 |
DOBUTAMINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
05/24/2019 |
EXJADE NDA #021882 |
SUPPL-31 |
DEFERASIROX |
NOVARTIS |
Efficacy |
Approval |
05/24/2019 |
OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078394 |
SUPPL-14 |
IBUPROFEN; OXYCODONE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
05/24/2019 |
CALCIPOTRIENE ANDA #090633 |
SUPPL-5 |
CALCIPOTRIENE |
GLENMARK PHARMS INC |
Labeling |
Approval |
05/24/2019 |
CALCIPOTRIENE ANDA #090633 |
SUPPL-6 |
CALCIPOTRIENE |
GLENMARK PHARMS INC |
Labeling |
Approval |
05/24/2019 |
PROLIA BLA #125320 |
SUPPL-195 |
DENOSUMAB |
AMGEN |
|
Approval |
05/24/2019 |
XGEVA BLA #125320 |
SUPPL-195 |
DENOSUMAB |
AMGEN |
|
Approval |
05/24/2019 |
METOCLOPRAMIDE HYDROCHLORIDE ANDA #202191 |
SUPPL-5 |
METOCLOPRAMIDE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
05/24/2019 |
JAKAFI NDA #202192 |
SUPPL-17 |
RUXOLITINIB PHOSPHATE |
INCYTE CORP |
Efficacy |
Approval |
05/24/2019 |
VRAYLAR NDA #204370 |
SUPPL-6 |
CARIPRAZINE HYDROCHLORIDE |
ABBVIE |
Efficacy |
Approval |
05/24/2019 |
JADENU NDA #206910 |
SUPPL-14 |
DEFERASIROX |
NOVARTIS PHARMS CORP |
Efficacy |
Approval |
05/24/2019 |
JADENU SPRINKLE NDA #207968 |
SUPPL-8 |
DEFERASIROX |
NOVARTIS |
Efficacy |
Approval |
05/24/2019 |
ALIQOPA NDA #209936 |
SUPPL-2 |
COPANLISIB DIHYDROCHLORIDE |
BAYER HEALTHCARE |
Labeling |
Approval |
05/24/2019 |
ASPIRIN AND DIPYRIDAMOLE ANDA #210318 |
ORIG-1 |
ASPIRIN; DIPYRIDAMOLE |
GLENMARK SPECLT |
|
Approval |
05/24/2019 |
BRAFTOVI NDA #210496 |
SUPPL-3 |
ENCORAFENIB |
ARRAY BIOPHARMA INC |
Efficacy |
Approval |
05/24/2019 |
DAPAGLIFLOZIN ANDA #211156 |
ORIG-1 |
DAPAGLIFLOZIN |
INVENTIA HLTHCARE |
|
Tentative Approval |
05/24/2019 |
PIQRAY NDA #212526 |
ORIG-1 |
ALPELISIB |
NOVARTIS |
Type 1 - New Molecular Entity |
Approval |
05/28/2019 |
REVLIMID NDA #021880 |
SUPPL-57 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
Efficacy |
Approval |
05/28/2019 |
PREZISTA NDA #021976 |
SUPPL-56 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
05/28/2019 |
LINEZOLID ANDA #200904 |
SUPPL-4 |
LINEZOLID |
SANDOZ |
Labeling |
Approval |
05/28/2019 |
LINEZOLID ANDA #200904 |
SUPPL-8 |
LINEZOLID |
SANDOZ |
Labeling |
Approval |
05/28/2019 |
PREZISTA NDA #202895 |
SUPPL-27 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
05/28/2019 |
CLOPIDOGREL BISULFATE ANDA #204359 |
SUPPL-3 |
CLOPIDOGREL BISULFATE |
RISING PHARMA |
Labeling |
Approval |
05/28/2019 |
CLOPIDOGREL BISULFATE ANDA #204359 |
SUPPL-4 |
CLOPIDOGREL BISULFATE |
RISING PHARMA |
Labeling |
Approval |
05/28/2019 |
CLOPIDOGREL BISULFATE ANDA #204359 |
SUPPL-5 |
CLOPIDOGREL BISULFATE |
RISING PHARMA |
Labeling |
Approval |
05/28/2019 |
CLOPIDOGREL BISULFATE ANDA #204359 |
SUPPL-7 |
CLOPIDOGREL BISULFATE |
RISING PHARMA |
Manufacturing (CMC) |
Approval |
05/28/2019 |
CLOPIDOGREL BISULFATE ANDA #204359 |
SUPPL-8 |
CLOPIDOGREL BISULFATE |
RISING PHARMA |
Labeling |
Approval |
05/28/2019 |
LOPERAMIDE HYDROCHLORIDE ANDA #206548 |
SUPPL-1 |
LOPERAMIDE HYDROCHLORIDE |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
05/28/2019 |
LINEZOLID ANDA #207354 |
SUPPL-3 |
LINEZOLID |
NANG KUANG PHARM CO |
Labeling |
Approval |
05/28/2019 |
LINEZOLID ANDA #207354 |
SUPPL-4 |
LINEZOLID |
NANG KUANG PHARM CO |
Labeling |
Approval |
05/28/2019 |
RANOLAZINE ANDA #208862 |
ORIG-1 |
RANOLAZINE |
ACTAVIS ELIZABETH |
|
Approval |
05/28/2019 |
MELPHALAN HYDROCHLORIDE ANDA #209826 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
GLAND PHARMA LTD |
|
Approval |
05/28/2019 |
RANOLAZINE ANDA #210054 |
ORIG-1 |
RANOLAZINE |
AJANTA PHARMA LTD |
|
Approval |
05/28/2019 |
HEPARIN SODIUM ANDA #211007 |
ORIG-1 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
|
Approval |
05/28/2019 |
RANOLAZINE ANDA #211291 |
ORIG-1 |
RANOLAZINE |
CIPLA |
|
Approval |
05/28/2019 |
RANOLAZINE ANDA #211707 |
ORIG-1 |
RANOLAZINE |
SUN PHARM |
|
Approval |
05/29/2019 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #016677 |
SUPPL-169 |
SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
05/29/2019 |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018016 |
SUPPL-67 |
SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
05/29/2019 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #019465 |
SUPPL-58 |
SODIUM CHLORIDE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
05/29/2019 |
DEXTROSE 5% IN PLASTIC CONTAINER NDA #019466 |
SUPPL-62 |
DEXTROSE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
05/29/2019 |
DEXTROSE 5% IN PLASTIC CONTAINER NDA #019479 |
SUPPL-54 |
DEXTROSE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
05/29/2019 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #019480 |
SUPPL-49 |
SODIUM CHLORIDE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
05/29/2019 |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #019759 |
SUPPL-50 |
SODIUM CHLORIDE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
05/29/2019 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #020178 |
SUPPL-21 |
SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
05/29/2019 |
BROVANA NDA #021912 |
SUPPL-32 |
ARFORMOTEROL TARTRATE |
LUPIN |
Labeling |
Approval |
05/29/2019 |
PERFOROMIST NDA #022007 |
SUPPL-15 |
FORMOTEROL FUMARATE |
MYLAN SPECLT |
Labeling |
Approval |
05/29/2019 |
ARCAPTA NEOHALER NDA #022383 |
SUPPL-7 |
INDACATEROL MALEATE |
NOVARTIS |
Labeling |
Approval |
05/29/2019 |
ROCURONIUM BROMIDE ANDA #091115 |
SUPPL-11 |
ROCURONIUM BROMIDE |
TAMARANG |
Labeling |
Approval |
05/29/2019 |
STRIVERDI RESPIMAT NDA #203108 |
SUPPL-8 |
OLODATEROL HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
05/29/2019 |
ANORO ELLIPTA NDA #203975 |
SUPPL-9 |
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
05/29/2019 |
MOVANTIK NDA #204760 |
SUPPL-8 |
NALOXEGOL OXALATE |
VALINOR |
Labeling |
Approval |
05/29/2019 |
DAPIPRAZOLE HYDROCHLORIDE ANDA #204902 |
ORIG-1 |
DAPIPRAZOLE HYDROCHLORIDE |
BARADAINA LLC |
|
Approval |
05/29/2019 |
PREZCOBIX NDA #205395 |
SUPPL-14 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
05/29/2019 |
STIOLTO RESPIMAT NDA #206756 |
SUPPL-11 |
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
05/29/2019 |
UTIBRON NDA #207930 |
SUPPL-4 |
GLYCOPYRROLATE; INDACATEROL MALEATE |
NOVARTIS |
Labeling |
Approval |
05/29/2019 |
BEVESPI AEROSPHERE NDA #208294 |
SUPPL-5 |
FORMOTEROL FUMARATE; GLYCOPYRROLATE |
ASTRAZENECA |
Labeling |
Approval |
05/29/2019 |
PLENVU NDA #209381 |
SUPPL-2 |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE |
SALIX |
Labeling |
Approval |
05/29/2019 |
XOSPATA NDA #211349 |
SUPPL-1 |
GILTERITINIB FUMARATE |
ASTELLAS |
Efficacy |
Approval |
05/29/2019 |
FULPHILA BLA #761075 |
SUPPL-4 |
PEGFILGRASTIM-JMDB |
MYLAN GMBH |
|
Approval |
05/30/2019 |
ANDROGEL NDA #021015 |
SUPPL-46 |
TESTOSTERONE |
BESINS HLTHCARE |
REMS |
Approval |
05/30/2019 |
TESTIM NDA #021454 |
SUPPL-29 |
TESTOSTERONE |
ENDO OPERATIONS |
REMS |
Approval |
05/30/2019 |
FORTESTA NDA #021463 |
SUPPL-21 |
TESTOSTERONE |
ENDO OPERATIONS |
REMS |
Approval |
05/30/2019 |
ALLEGRA NDA #021963 |
SUPPL-7 |
FEXOFENADINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
05/30/2019 |
ANDROGEL NDA #022309 |
SUPPL-21 |
TESTOSTERONE |
BESINS HLTHCARE |
REMS |
Approval |
05/30/2019 |
MOZOBIL NDA #022311 |
SUPPL-20 |
PLERIXAFOR |
GENZYME |
Labeling |
Approval |
05/30/2019 |
MYOZYME BLA #125141 |
SUPPL-222 |
ALGLUCOSIDASE ALFA |
GENZYME |
|
Approval |
05/30/2019 |
LUMIZYME BLA #125291 |
SUPPL-148 |
ALGLUCOSIDASE ALFA |
GENZYME |
|
Approval |
05/30/2019 |
FYCOMPA NDA #202834 |
SUPPL-16 |
PERAMPANEL |
CATALYST PHARMS |
Labeling |
Approval |
05/30/2019 |
VOGELXO NDA #204399 |
SUPPL-11 |
TESTOSTERONE |
UPSHER SMITH LABS |
REMS |
Approval |
05/30/2019 |
VIGABATRIN ANDA #208218 |
SUPPL-4 |
VIGABATRIN |
ENDO OPERATIONS |
REMS |
Approval |
05/30/2019 |
FYCOMPA NDA #208277 |
SUPPL-4 |
PERAMPANEL |
CATALYST PHARMS |
Labeling |
Approval |
05/30/2019 |
VIGABATRIN ANDA #209822 |
SUPPL-2 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
05/30/2019 |
VIGABATRIN ANDA #209824 |
SUPPL-2 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
05/30/2019 |
VIGABATRIN ANDA #210155 |
SUPPL-2 |
VIGABATRIN |
AMNEAL PHARMS |
REMS |
Approval |
05/30/2019 |
VIGADRONE ANDA #210196 |
SUPPL-1 |
VIGABATRIN |
AUCTA |
REMS |
Approval |
05/30/2019 |
SYMTUZA NDA #210455 |
SUPPL-4 |
COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
JANSSEN PRODS |
Labeling |
Approval |
05/30/2019 |
VIGABATRIN ANDA #211481 |
SUPPL-1 |
VIGABATRIN |
DR REDDYS |
REMS |
Approval |
05/31/2019 |
SABRIL NDA #020427 |
SUPPL-19 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
REMS |
Approval |
05/31/2019 |
SABRIL NDA #022006 |
SUPPL-21 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
REMS |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #076802 |
SUPPL-20 |
GLIMEPIRIDE |
TEVA |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #077091 |
SUPPL-15 |
GLIMEPIRIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #077091 |
SUPPL-17 |
GLIMEPIRIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #077274 |
SUPPL-9 |
GLIMEPIRIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #077624 |
SUPPL-7 |
GLIMEPIRIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #077911 |
SUPPL-4 |
GLIMEPIRIDE |
CARLSBAD |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #077911 |
SUPPL-5 |
GLIMEPIRIDE |
CARLSBAD |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #078181 |
SUPPL-14 |
GLIMEPIRIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
05/31/2019 |
MEMANTINE HYDROCHLORIDE ANDA #200891 |
SUPPL-6 |
MEMANTINE HYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
05/31/2019 |
GLIMEPIRIDE ANDA #202759 |
SUPPL-8 |
GLIMEPIRIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
05/31/2019 |
PROCYSBI NDA #203389 |
SUPPL-22 |
CYSTEAMINE BITARTRATE |
HORIZON |
Labeling |
Approval |
05/31/2019 |
TESTOSTERONE ANDA #204255 |
SUPPL-5 |
TESTOSTERONE |
PADAGIS ISRAEL |
REMS |
Approval |
05/31/2019 |
ENTECAVIR ANDA #205740 |
SUPPL-2 |
ENTECAVIR |
HETERO LABS LTD V |
Labeling |
Approval |
05/31/2019 |
ENTECAVIR ANDA #205740 |
SUPPL-3 |
ENTECAVIR |
HETERO LABS LTD V |
Labeling |
Approval |
05/31/2019 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #206159 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ENDO OPERATIONS |
|
Approval |
05/31/2019 |
BUSULFAN ANDA #209580 |
SUPPL-1 |
BUSULFAN |
AMNEAL |
Labeling |
Approval |
05/31/2019 |
BUSULFAN ANDA #209580 |
SUPPL-2 |
BUSULFAN |
AMNEAL |
Labeling |
Approval |
05/31/2019 |
ATOVAQUONE ANDA #210510 |
ORIG-1 |
ATOVAQUONE |
ABHAI LLC |
|
Approval |
05/31/2019 |
FELBAMATE ANDA #211333 |
ORIG-1 |
FELBAMATE |
NOVITIUM PHARMA |
|
Approval |
05/31/2019 |
SILDENAFIL CITRATE ANDA #212260 |
ORIG-1 |
SILDENAFIL CITRATE |
NOVITIUM PHARMA |
|
Approval |