Drugs@FDA: FDA Approved Drug Products

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All Approvals
August 2018

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 August 18, 2018.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/01/2018 VASOTEC
NDA #018998		 SUPPL-83 ENALAPRIL MALEATE VALEANT PHARMS NORTH Labeling Approval
08/01/2018 DEPO-TESTOSTERONE
ANDA #085635		 SUPPL-40 TESTOSTERONE CYPIONATE PHARMACIA AND UPJOHN Labeling Approval
08/01/2018 ROCURONIUM BROMIDE
ANDA #091115		 SUPPL-9 ROCURONIUM BROMIDE TAMARANG Labeling Approval
08/01/2018 OXACILLIN SODIUM
ANDA #201539		 SUPPL-7 OXACILLIN SODIUM AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
08/01/2018 VANCOMYCIN HYDROCHLORIDE
ANDA #204125		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE CFT PHARMS LLC Labeling Approval
08/01/2018 CABERGOLINE
ANDA #204735		 ORIG-1 CABERGOLINE INGENUS PHARMS LLC Approval
08/01/2018 GENVOYA
NDA #207561		 SUPPL-17 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
08/01/2018 RANITIDINE HYDROCHLORIDE
ANDA #210010		 ORIG-1 RANITIDINE HYDROCHLORIDE VIVIMED GLOBAL Approval
08/01/2018 CINACALCET HYDROCHLORIDE
ANDA #210207		 ORIG-1 CINACALCET HYDROCHLORIDE PIRAMAL HLTHCARE UK Approval
08/02/2018 ADVIL LIQUI-GELS
NDA #020402		 SUPPL-46 IBUPROFEN PFIZER Labeling Approval
08/02/2018 ADVIL MIGRAINE LIQUI-GELS
NDA #020402		 SUPPL-46 IBUPROFEN PFIZER Labeling Approval
08/02/2018 VALCYTE
NDA #021304		 SUPPL-14 VALGANCICLOVIR HYDROCHLORIDE HOFFMANN LA ROCHE Efficacy Approval
08/02/2018 DOCETAXEL
NDA #022234		 SUPPL-10 DOCETAXEL HOSPIRA INC Labeling Approval
08/02/2018 VALCYTE
NDA #022257		 SUPPL-9 VALGANCICLOVIR HYDROCHLORIDE HOFFMANN LA ROCHE Efficacy Approval
08/02/2018 HUMIRA
BLA #125057		 SUPPL-406 ADALIMUMAB ABBVIE INC Approval
08/02/2018 METHADONE HYDROCHLORIDE
ANDA #210484		 ORIG-1 METHADONE HYDROCHLORIDE ELITE LABS INC Approval
08/02/2018 BIMATOPROST
ANDA #210515		 ORIG-1 BIMATOPROST ALEMBIC PHARMS LTD Tentative Approval
08/02/2018 TIGECYCLINE
NDA #211158		 ORIG-1 TIGECYCLINE AMNEAL PHARMS LLC Type 5 - New Formulation or New Manufacturer Approval
08/03/2018 TADALAFIL
ANDA #200630		 ORIG-1 TADALAFIL MYLAN PHARMS INC Approval
08/03/2018 STENDRA
NDA #202276		 SUPPL-18 AVANAFIL METUCHEN PHARMS Efficacy Approval
08/03/2018 NUVESSA
NDA #205223		 SUPPL-2 METRONIDAZOLE CHEMO RESEARCH SL Efficacy Approval
08/03/2018 JADENU
NDA #206910		 SUPPL-10 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
08/03/2018 JADENU SPRINKLE
NDA #207968		 SUPPL-5 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
08/03/2018 LIDOCAINE HYDROCHLORIDE
ANDA #208474		 ORIG-1 LIDOCAINE HYDROCHLORIDE B BRAUN MEDICAL INC Approval
08/03/2018 DICLOFENAC SODIUM
ANDA #209903		 ORIG-1 DICLOFENAC SODIUM CIPLA LTD Approval
08/06/2018 GALLIUM CITRATE GA 67
NDA #017478		 SUPPL-16 GALLIUM CITRATE GA-67 LANTHEUS MEDCL Labeling Approval
08/06/2018 CYTOVENE
NDA #019661		 SUPPL-37 GANCICLOVIR SODIUM ROCHE PALO Efficacy Approval
08/06/2018 PRIMAXIN
NDA #050587		 SUPPL-80 CILASTATIN SODIUM; IMIPENEM MERCK Manufacturing (CMC) Approval
08/06/2018 ROFLUMILAST
ANDA #208272		 ORIG-1 ROFLUMILAST TORRENT PHARMS LTD Approval
08/06/2018 MAVYRET
NDA #209394		 SUPPL-2 GLECAPREVIR; PIBRENTASVIR ABBVIE INC Efficacy Approval
08/07/2018 KETALAR
NDA #016812		 SUPPL-40 KETAMINE HYDROCHLORIDE PAR STERILE PRODUCTS Labeling Approval
08/07/2018 STRIBILD
NDA #203100		 SUPPL-32 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
08/07/2018 TOLCAPONE
ANDA #208937		 ORIG-1 TOLCAPONE INGENUS PHARMS LLC Approval
08/07/2018 AXITINIB
ANDA #210234		 ORIG-1 AXITINIB TEVA PHARMS Tentative Approval
08/07/2018 ORKAMBI
NDA #211358		 ORIG-1 LUMACAFTOR;IVACAFTOR VERTEX PHARMS Type 3 - New Dosage Form Approval
08/08/2018 LASIX
NDA #016273		 SUPPL-69 FUROSEMIDE US PHARM HOLDINGS Labeling Approval
08/08/2018 BUMEX
NDA #018225		 SUPPL-28 BUMETANIDE VALIDUS PHARMS Labeling Approval
08/08/2018 LOTENSIN HCT
NDA #020033		 SUPPL-62 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE US PHARMS HOLDINGS I Labeling Approval
08/08/2018 SOLUPREP
NDA #208288		 ORIG-1 2%CHLORHEXIDINE GLUCONATE;70% ISOPROPYL ALCOHOL 3M Type 5 - New Formulation or New Manufacturer Approval
08/08/2018 JORNAY PM
NDA #209311		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE IRONSHORE PHARMA DEV INC Type 3 - New Dosage Form Approval
08/08/2018 ARAKODA
NDA #210607		 ORIG-1 TAFENOQUINE 60 DEGREES PHARMS LLC Type 5 - New Formulation or New Manufacturer Approval
08/08/2018 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ANDA #210880		 ORIG-1 DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE HETERO LABS UNIT III Type 4 - New Combination Tentative Approval
08/08/2018 POTASSIUM CHLORIDE
ANDA #211067		 ORIG-1 POTASSIUM CHLORIDE APOTEX INC Approval
08/08/2018 POTELIGEO
BLA #761051		 ORIG-1 MOGAMULIZUMAB-KPKC KYOWA KIRIN Approval
08/09/2018 ATAZANAVIR SULFATE
ANDA #200626		 ORIG-1 ATAZANAVIR SULFATE CIPLA LTD Approval
08/09/2018 DICLOFENAC SODIUM
ANDA #202769		 SUPPL-1 DICLOFENAC SODIUM TELIGENT PHARMA INC Labeling Approval
08/09/2018 RYZODEG 70/30
NDA #203313		 SUPPL-5 INSULIN ASPART; INSULIN DEGLUDEC NOVO NORDISK INC Efficacy Approval
08/09/2018 TRESIBA
NDA #203314		 SUPPL-9 INSULIN DEGLUDEC NOVO NORDISK INC Efficacy Approval
08/09/2018 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #203407		 ORIG-1 METHOTREXATE SODIUM SAGENT PHARMS Approval
08/09/2018 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
ANDA #208328		 SUPPL-1 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE AMNEAL PHARMS Manufacturing (CMC) Tentative Approval
08/09/2018 NETSPOT
NDA #208547		 SUPPL-13 GALLIUM DOTATATE GA-68 AAA USA INC Manufacturing (CMC) Approval
08/09/2018 ESTRADIOL
ANDA #210194		 SUPPL-2 ESTRADIOL PERRIGO UK FINCO Labeling Approval
08/09/2018 ESTRADIOL
ANDA #210488		 SUPPL-1 ESTRADIOL TEVA PHARMS USA Labeling Approval
08/09/2018 LARTRUVO
BLA #761038		 SUPPL-9 OLARATUMAB ELI LILLY AND CO Approval
08/10/2018 HIBICLENS
NDA #017768		 SUPPL-48 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Manufacturing (CMC) Approval
08/10/2018 GLUCOTROL XL
NDA #020329		 SUPPL-32 GLIPIZIDE PFIZER Labeling Approval
08/10/2018 LIPITOR
NDA #020702		 SUPPL-71 ATORVASTATIN CALCIUM PFIZER Labeling Approval
08/10/2018 NEXIUM IV
NDA #021689		 SUPPL-33 ESOMEPRAZOLE SODIUM ASTRAZENECA PHARMS Labeling Approval
08/10/2018 MOMETASONE FUROATE
ANDA #078541		 SUPPL-11 MOMETASONE FUROATE GLENMARK GENERICS Labeling Approval
08/10/2018 INLYTA
NDA #202324		 SUPPL-8 AXITINIB PF PRISM CV Labeling Approval
08/10/2018 BRIMONIDINE TARTRATE
ANDA #203172		 ORIG-1 BRIMONIDINE TARTRATE SANDOZ INC Tentative Approval
08/10/2018 PIPERACILLIN AND TAZOBACTAM
ANDA #204959		 ORIG-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM QILU TIANHE Approval
08/10/2018 RITONAVIR
ANDA #205801		 ORIG-1 RITONAVIR WEST-WARD PHARMS INT Tentative Approval
08/10/2018 AKOVAZ
NDA #208289		 SUPPL-2 EPHEDRINE SULFATE FLAMEL IRELAND LTD Labeling Approval
08/10/2018 AKOVAZ
NDA #208289		 SUPPL-3 EPHEDRINE SULFATE FLAMEL IRELAND LTD Labeling Approval
08/10/2018 GALAFOLD
NDA #208623		 ORIG-1 MIGALASTAT HYDROCHLORIDE AMICUS THERAPEUTICS US INC Type 1 - New Molecular Entity Approval
08/10/2018 INGREZZA
NDA #209241		 SUPPL-3 VALBENAZINE TOSYLATE NEUROCRINE Labeling Approval
08/10/2018 SODIUM NITROPRUSSIDE
ANDA #209584		 ORIG-1 SODIUM NITROPRUSSIDE APICORE US Approval
08/10/2018 ANNOVERA
NDA #209627		 ORIG-1 SEGESTERONE ACETATE;ETHINYL ESTRADIOL THE POPULATION COUNCIL INC Type 1 - New Molecular Entity Approval
08/10/2018 ONPATTRO
NDA #210922		 ORIG-1 PATISIRAN ALNYLAM PHARMA INC Type 1 - New Molecular Entity Approval
08/13/2018 VENLAFAXINE HYDROCHLORIDE
ANDA #204889		 SUPPL-1 VENLAFAXINE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
08/13/2018 LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
NDA #205626		 ORIG-1 LAMIVUDINE;NEVIRAPINE;ZIDOVUDINE MICRO LABS LTD Type 4 - New Combination Approval
08/13/2018 IMATINIB MESYLATE
ANDA #206547		 ORIG-1 IMATINIB MESYLATE DR REDDYS LABS LTD Approval
08/13/2018 POSACONAZOLE
ANDA #209983		 ORIG-1 POSACONAZOLE FRESENIUS KABI USA Tentative Approval
08/13/2018 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #210137		 ORIG-1 FEXOFENADINE HYDROCHLORIDE UNIQUE PHARM LABS Approval
08/13/2018 DIMETHYL FUMARATE
ANDA #210402		 ORIG-1 DIMETHYL FUMARATE AMNEAL PHARMS CO Tentative Approval
08/14/2018 CYRAMZA
BLA #125477		 SUPPL-30 RAMUCIRUMAB ELI LILLY AND CO Approval
08/14/2018 ESTRADIOL
ANDA #201675		 SUPPL-5 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
08/14/2018 ESTRADIOL
ANDA #201675		 SUPPL-6 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
08/14/2018 CEQUA
NDA #210913		 ORIG-1 CYCLOSPORINE SUN PHARMA GLOBAL Type 5 - New Formulation or New Manufacturer Approval
08/15/2018 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #022343		 ORIG-1 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Type 4 - New Combination Approval
08/15/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040432		 SUPPL-10 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040482		 SUPPL-18 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
08/15/2018 COSMEGEN
NDA #050682		 SUPPL-33 DACTINOMYCIN RECORDATI RARE Efficacy Approval
08/15/2018 COSMEGEN
NDA #050682		 SUPPL-34 DACTINOMYCIN RECORDATI RARE Efficacy Approval
08/15/2018 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
ANDA #074736		 SUPPL-32 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE WATSON LABS Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-20 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-22 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-23 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 REPREXAIN
ANDA #076642		 SUPPL-20 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 REPREXAIN
ANDA #076642		 SUPPL-22 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 REPREXAIN
ANDA #076642		 SUPPL-23 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077454		 SUPPL-1 HYDROCODONE BITARTRATE; IBUPROFEN ACTAVIS LABS FL INC Labeling Approval
08/15/2018 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078769		 SUPPL-20 IBUPROFEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
08/15/2018 ESTRACE
ANDA #086069		 SUPPL-24 ESTRADIOL ALLERGAN SALES LLC Labeling Approval
08/15/2018 PREPOPIK
NDA #202535		 SUPPL-5 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FERRING PHARMS INC Efficacy Approval
08/15/2018 KALYDECO
NDA #203188		 SUPPL-28 IVACAFTOR VERTEX PHARMS Efficacy Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #204575		 SUPPL-1 HYDROCODONE BITARTRATE; IBUPROFEN AUROLIFE PHARMA LLC Labeling Approval
08/15/2018 ATRACURIUM BESYLATE
ANDA #206011		 SUPPL-2 ATRACURIUM BESYLATE AUROBINDO PHARMA LTD Labeling Approval
08/15/2018 ORKAMBI
NDA #206038		 SUPPL-10 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Labeling Approval
08/15/2018 ESTRADIOL
ANDA #206685		 ORIG-1 ESTRADIOL MYLAN TECHNOLOGIES Approval
08/15/2018 LENVIMA
NDA #206947		 SUPPL-7 LENVATINIB MESYLATE EISAI INC Efficacy Approval
08/15/2018 KALYDECO
NDA #207925		 SUPPL-7 IVACAFTOR VERTEX PHARMS INC Efficacy Approval
08/15/2018 ESTRADIOL
ANDA #209767		 SUPPL-1 ESTRADIOL ALVOGEN PINE BROOK Labeling Approval
08/16/2018 ABRAXANE
NDA #021660		 SUPPL-45 PACLITAXEL ABRAXIS BIOSCIENCE Labeling Approval
08/16/2018 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076631		 SUPPL-32 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
08/16/2018 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076688		 SUPPL-15 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE MYLAN Labeling Approval
08/16/2018 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078794		 SUPPL-4 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE APOTEX INC Labeling Approval
08/16/2018 EPINEPHRINE (AUTOINJECTOR)
ANDA #090589		 ORIG-1 EPINEPHRINE TEVA PHARMS USA Approval
08/16/2018 EYLEA
BLA #125387		 SUPPL-56 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
08/16/2018 EYLEA
BLA #125387		 SUPPL-58 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
08/16/2018 KEYTRUDA
BLA #125514		 SUPPL-46 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/16/2018 OPDIVO
BLA #125554		 SUPPL-67 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
08/16/2018 LACOSAMIDE
ANDA #206355		 ORIG-1 LACOSAMIDE APOTEX INC Tentative Approval
08/16/2018 TADALAFIL
ANDA #209167		 ORIG-1 TADALAFIL ACCORD HLTHCARE INC Tentative Approval
08/16/2018 LOPINAVIR; RITONAVIR
NDA #210540		 ORIG-1 LOPINAVIR; RITONAVIR MYLAN LABS LTD Type 5 - New Formulation or New Manufacturer Tentative 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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