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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 2019

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on May 03, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
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 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 MYLAN 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 MYLAN 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 ANCHEN PHARMS Labeling Approval
05/03/2019 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183		 SUPPL-21 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE RISING 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 MYLAN LABS LTD Labeling Approval
05/03/2019 GEMCITABINE HYDROCHLORIDE
ANDA #200145		 SUPPL-11 GEMCITABINE HYDROCHLORIDE MYLAN LABS LTD 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 MYLAN ASI 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 PENICILLAMINE
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 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 AUXILIUM PHARMS LLC Labeling Approval
05/10/2019 FORTESTA
NDA #021463		 SUPPL-20 TESTOSTERONE ENDO PHARMS 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 PAR PHARM INC 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 PHARMS 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 PAR STERILE PRODUCTS 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 RIVAROXABAN
ANDA #208549		 ORIG-1 RIVAROXABAN PRINSTON INC Tentative 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 PHARMS 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 PHARMS SA 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 Labeling Approval
05/28/2019 CLOPIDOGREL BISULFATE
ANDA #204359		 SUPPL-4 CLOPIDOGREL BISULFATE RISING Labeling Approval
05/28/2019 CLOPIDOGREL BISULFATE
ANDA #204359		 SUPPL-5 CLOPIDOGREL BISULFATE RISING Labeling Approval
05/28/2019 CLOPIDOGREL BISULFATE
ANDA #204359		 SUPPL-7 CLOPIDOGREL BISULFATE RISING Manufacturing (CMC) Approval
05/28/2019 CLOPIDOGREL BISULFATE
ANDA #204359		 SUPPL-8 CLOPIDOGREL BISULFATE RISING 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 WOODWARD 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 AUXILIUM PHARMS LLC REMS Approval
05/30/2019 FORTESTA
NDA #021463		 SUPPL-21 TESTOSTERONE ENDO PHARMS 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 PAR PHARM INC 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 MYLAN 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 PAR PHARM INC 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
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