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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