Drugs@FDA: FDA Approved Drug Products

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All Approvals
June 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on June 16, 2019.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/03/2019 MIRALAX
NDA #022015		 SUPPL-35 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076737		 SUPPL-9 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076737		 SUPPL-13 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076744		 SUPPL-8 TESTOSTERONE PAR PHARM Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076744		 SUPPL-9 TESTOSTERONE PAR PHARM Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076744		 SUPPL-10 TESTOSTERONE PAR PHARM Labeling Approval
06/03/2019 LANSOPRAZOLE
ANDA #201921		 SUPPL-6 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
06/03/2019 ELIQUIS
NDA #202155		 SUPPL-21 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
06/03/2019 ZYTIGA
NDA #202379		 SUPPL-27 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
06/03/2019 ZYTIGA
NDA #202379		 SUPPL-28 ABIRATERONE ACETATE JANSSEN BIOTECH Efficacy Approval
06/03/2019 BROMFENAC SODIUM
ANDA #203368		 ORIG-1 BROMFENAC SODIUM INNOPHARMA LICENSING Approval
06/03/2019 ZERBAXA
NDA #206829		 SUPPL-8 CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM CUBIST PHARMS LLC Efficacy Approval
06/03/2019 EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206894		 ORIG-1 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE CIPLA Approval
06/03/2019 ERLOTINIB
ANDA #208396		 ORIG-1 ERLOTINIB APOTEX INC Tentative Approval
06/03/2019 TESTOSTERONE
ANDA #208560		 SUPPL-1 TESTOSTERONE LUPIN ATLANTIS Labeling Approval
06/03/2019 LEFLUNOMIDE
ANDA #212453		 ORIG-1 LEFLUNOMIDE ABHAI LLC Approval
06/04/2019 TESTOSTERONE
ANDA #208061		 SUPPL-2 TESTOSTERONE LUPIN LTD REMS Approval
06/04/2019 TESTOSTERONE
ANDA #208620		 SUPPL-1 TESTOSTERONE DR REDDYS Labeling Approval
06/04/2019 TESTOSTERONE
ANDA #208620		 SUPPL-2 TESTOSTERONE DR REDDYS Labeling Approval
06/04/2019 TESTOSTERONE
ANDA #209533		 SUPPL-4 TESTOSTERONE CIPLA REMS Approval
06/04/2019 RANOLAZINE
ANDA #211829		 ORIG-1 RANOLAZINE SCIEGEN PHARMS INC Approval
06/04/2019 EMGALITY
BLA #761063		 SUPPL-3 GALCANEZUMAB-GNLM ELI LILLY AND CO Approval
06/05/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #209716		 ORIG-1 ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY Approval
06/05/2019 CARBIDOPA AND LEVODOPA
ANDA #210341		 ORIG-1 CARBIDOPA; LEVODOPA ALEMBIC PHARMS LTD Approval
06/06/2019 TAXOTERE
NDA #020449		 SUPPL-80 DOCETAXEL SANOFI AVENTIS US Labeling Approval
06/06/2019 TAXOTERE
NDA #020449		 SUPPL-82 DOCETAXEL SANOFI AVENTIS US Labeling Approval
06/06/2019 NUCALA
BLA #125526		 SUPPL-13 MEPOLIZUMAB GLAXOSMITHKLINE LLC Approval
06/06/2019 ANORO ELLIPTA
NDA #203975		 SUPPL-10 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Efficacy Approval
06/06/2019 INCRUSE ELLIPTA
NDA #205382		 SUPPL-10 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Efficacy Approval
06/06/2019 DESMOPRESSIN ACETATE
ANDA #208357		 ORIG-1 DESMOPRESSIN ACETATE NOVAST LABS Approval
06/06/2019 NUCALA
BLA #761122		 ORIG-1 MEPOLIZUMAB GLAXOSMITHKLINE Approval
06/07/2019 THALOMID
NDA #020785		 SUPPL-67 THALIDOMIDE CELGENE Labeling Approval
06/07/2019 TINDAMAX
NDA #021618		 SUPPL-6 TINIDAZOLE MISSION PHARMA Labeling Approval
06/07/2019 VIVITROL
NDA #021897		 SUPPL-44 NALTREXONE ALKERMES REMS Approval
06/07/2019 EMFLAZA
NDA #208684		 SUPPL-3 DEFLAZACORT PTC THERAP Efficacy Approval
06/07/2019 EMFLAZA
NDA #208685		 SUPPL-3 DEFLAZACORT PTC THERAP Efficacy Approval
06/07/2019 TOFACITINIB
ANDA #209633		 ORIG-1 TOFACITINIB BRECKENRIDGE PHARMS Tentative Approval
06/07/2019 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #210967		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE AUROBINDO PHARMA LTD Approval
06/10/2019 KEYTRUDA
BLA #125514		 SUPPL-52 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/10/2019 OPSUMIT
NDA #204410		 SUPPL-19 MACITENTAN ACTELION PHARMS LTD REMS Approval
06/10/2019 ZEMBRACE SYMTOUCH
NDA #208223		 SUPPL-5 SUMATRIPTAN SUCCINATE DR REDDYS Efficacy Approval
06/10/2019 NIACIN
ANDA #212017		 ORIG-1 NIACIN YICHANG HUMANWELL Approval
06/10/2019 POLIVY
BLA #761121		 ORIG-1 POLATUZUMAB VEDOTIN-PIIQ GENENTECH Approval
06/11/2019 FURADANTIN
NDA #009175		 SUPPL-46 NITROFURANTOIN CASPER PHARMA LLC Labeling Approval
06/11/2019 PEPCID COMPLETE
NDA #020958		 SUPPL-29 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE J AND J CONSUMER INC Labeling Approval
06/11/2019 MEN'S ROGAINE
NDA #021812		 SUPPL-14 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
06/11/2019 WOMEN'S ROGAINE
NDA #021812		 SUPPL-14 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
06/11/2019 NUEDEXTA
NDA #021879		 SUPPL-14 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE AVANIR PHARMS Labeling Approval
06/11/2019 VIMPAT
NDA #022253		 SUPPL-45 LACOSAMIDE UCB INC Labeling Approval
06/11/2019 VIMPAT
NDA #022254		 SUPPL-35 LACOSAMIDE UCB INC Labeling Approval
06/11/2019 VIMPAT
NDA #022255		 SUPPL-26 LACOSAMIDE UCB INC Labeling Approval
06/11/2019 PROGRAF
NDA #050708		 SUPPL-50 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 PROGRAF
NDA #050709		 SUPPL-42 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 ACTEMRA
BLA #125276		 SUPPL-127 TOCILIZUMAB GENENTECH Approval
06/11/2019 ACTEMRA
BLA #125472		 SUPPL-40 TOCILIZUMAB GENENTECH Approval
06/11/2019 QUETIAPINE FUMARATE
ANDA #202939		 SUPPL-2 QUETIAPINE FUMARATE INTELLIPHARMACEUTICS Manufacturing (CMC) Approval
06/11/2019 ASTAGRAF XL
NDA #204096		 SUPPL-7 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 TESTOSTERONE
ANDA #205328		 SUPPL-2 TESTOSTERONE ACTAVIS LABS UT INC REMS Approval
06/11/2019 TIGECYCLINE
ANDA #206335		 ORIG-1 TIGECYCLINE AUROBINDO PHARMA LTD Approval
06/11/2019 POTASSIUM CHLORIDE
ANDA #209026		 ORIG-1 POTASSIUM CHLORIDE PRINSTON INC Approval
06/11/2019 PROGRAF
NDA #210115		 SUPPL-2 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ANDA #210663		 ORIG-1 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE BRECKENRIDGE PHARM Approval
06/12/2019 DIOVAN HCT
NDA #020818		 SUPPL-75 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
06/12/2019 DIOVAN
NDA #021283		 SUPPL-53 VALSARTAN NOVARTIS Labeling Approval
06/12/2019 EXFORGE
NDA #021990		 SUPPL-33 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
06/12/2019 EXFORGE HCT
NDA #022314		 SUPPL-27 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
06/12/2019 BUPROPION HYDROCHLORIDE
ANDA #077284		 SUPPL-42 BUPROPION HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
06/12/2019 MESALAMINE
ANDA #202065		 ORIG-1 MESALAMINE SANDOZ INC Approval
06/12/2019 PALIPERIDONE
ANDA #204452		 ORIG-1 PALIPERIDONE INVENTIA HLTHCARE Approval
06/12/2019 LORATADINE
ANDA #210033		 ORIG-1 LORATADINE PERRIGO PHARMA INTL Approval
06/12/2019 DAPAGLIFLOZIN
ANDA #211545		 ORIG-1 DAPAGLIFLOZIN ALKEM LABS LTD Tentative Approval
06/12/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #211594		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE ALVOGEN MALTA Tentative Approval
06/12/2019 VANCOMYCIN HYDROCHLORIDE
ANDA #212332		 ORIG-1 VANCOMYCIN HYDROCHLORIDE HAINAN POLY PHARM Approval
06/13/2019 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-101 CLINDAMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
06/13/2019 NUZYRA
NDA #209816		 SUPPL-2 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209816		 SUPPL-3 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209816		 SUPPL-4 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209817		 SUPPL-1 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209817		 SUPPL-2 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209817		 SUPPL-3 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 AMJEVITA
BLA #761024		 SUPPL-4 ADALIMUMAB-ATTO AMGEN INC Approval
06/13/2019 KANJINTI
BLA #761073		 ORIG-1 TRASTUZUMAB-ANNS AMGEN INC Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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