Drugs@FDA: FDA Approved Drug Products

New and Generic Drug Approvals

February 22, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Jetrea
BLA #125422
Ocriplasmin Injectable; Intravitreal SUPPL-38 Thrombogenics, Inc LABELING Approved
Revlimid
NDA #021880
Lenalidomide Capsule; Oral SUPPL-49 Celgene LABELING Approved
Vizamyl
NDA #203137
Flutemetamol F-18 Injectable; Intravenous SUPPL-8 Ge Healthcare LABELING Approved

February 21, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Doxazosin Mesylate
ANDA #075509
Doxazosin Mesylate Tablet; Oral SUPPL-18 Mylan LABELING Approved
Doxazosin Mesylate
ANDA #075536
Doxazosin Mesylate Tablet; Oral SUPPL-19 Teva LABELING Approved
Doxazosin Mesylate
ANDA #075580
Doxazosin Mesylate Tablet; Oral SUPPL-21 Apotex LABELING Approved
Doxazosin Mesylate
ANDA #075646
Doxazosin Mesylate Tablet; Oral SUPPL-3 Sandoz LABELING Approved
Doxazosin Mesylate
ANDA #202824
Doxazosin Mesylate Tablet; Oral SUPPL-2 Accord Hlthcare LABELING Approved
Losartan Potassium and Hydrochlorothiazide
ANDA #077732
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-8 West-Ward Pharms Int LABELING Approved
Losartan Potassium and Hydrochlorothiazide
ANDA #090528
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-15 Torrent Pharms LABELING Approved
Losartan Potassium and Hydrochlorothiazide
ANDA #091629
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-15 Aurobindo Pharma LABELING Approved
Losartan Potassium and Hydrochlorothiazide
ANDA #201682
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-5 Ipca Labs Ltd LABELING Approved
Tasigna
NDA #022068
Nilotinib Hydrochloride Monohydrate Capsule; Oral SUPPL-24 Novartis LABELING Approved

February 17, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Auvi-Q
NDA #201739
Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-6 Kaleo Inc Approved
Ciloxan
NDA #020369
Ciprofloxacin Hydrochloride Ointment; Ophthalmic SUPPL-22 Novartis Pharms Corp LABELING Approved
Dicyclomine Hydrochloride
ANDA #208353
Dicyclomine Hydrochloride Injectable; Injection ORIG-1 Luitpold Pharms Inc Approved
Doxorubicin Hydrochloride
ANDA #208888
Doxorubicin Hydrochloride Injectable; Injection ORIG-1 Amneal Pharms Co Approved
Fesoterodine Fumarate
ANDA #205007
Fesoterodine Fumarate Tablet, Extended Release; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Ganciclovir
NDA #209347
Ganciclovir Injectable; Injection ORIG-1 Exela Pharma Scs Llc TYPE 5 Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Paddock Llc MANUF (CMC) Approved
Losartan Potassium and Hydrochlorothiazide
ANDA #077157
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-10 Teva Pharms LABELING Approved
Minoxidil (For Men)
ANDA #208092
Minoxidil Aerosol, Foam; Topical ORIG-1 Watson Labs Inc Approved
Minoxidil (For Men)
ANDA #208092
Minoxidil Aerosol, Foam; Topical ORIG-2 Watson Labs Inc Tentative Approval
Moxeza
NDA #022428
Moxifloxacin Hydrochloride Solution/Drops; Ophthalmic SUPPL-9 Novartis Pharms Corp LABELING Approved
Piperacillin; Tazobactam
ANDA #206204
Piperacillin;Tazobactam Injectable; Injection ORIG-1 Fresenius Kabi Usa Tentative Approval
Rabeprazole Sodium
ANDA #205761
Rabeprazole Sodium Tablet, Delayed Release; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Tuzistra Xr
NDA #207768
Chlorpheniramine Polistirex; Codeine Polistirex Suspension, Extended Release; Oral SUPPL-3 Vernalis R and D Ltd MANUF (CMC) Approved
Zarxio
BLA #125553
Filgrastim-Sndz Injectable; Injection SUPPL-7 Sandoz Inc LABELING Approved
Zegerid Otc
NDA #022281
Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-11 Bayer Healthcare Llc LABELING Approved
Ziprasidone Hydrochloride
ANDA #204375
Ziprasidone Hydrochloride Capsule; Oral ORIG-1 Macleods Pharms Ltd Approved

February 16, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Clobetasol Propionate
ANDA #206378
Clobetasol Propionate Spray; Topical ORIG-1 Zydus Pharms Usa Inc Approved
Fluconazole
ANDA #208963
Fluconazole Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Fluticasone Propionate
ANDA #076668
Fluticasone Propionate Ointment; Topical SUPPL-2 Perrigo New York LABELING Approved
Losartan Potassium and Hydrochlorothiazide
ANDA #077948
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-11 Sandoz LABELING Approved
Nucala
BLA #125526
Mepolizumab Injectable; Subcutaneous Lyophilized Power SUPPL-2 Glaxosmithkline Llc LABELING Approved
Vascepa
NDA #202057
Icosapent Ethyl Capsule; Oral SUPPL-19 Amarin Pharms MANUF (CMC) Approved

February 15, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Carboplatin
ANDA #207324
Carboplatin Injectable; Iv (Infusion) ORIG-1 Gland Pharma Ltd Approved
Docetaxel
ANDA #203170
Docetaxel Injectable; Injection ORIG-1 Jiangsu Hengrui Med Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-4 Gilead Sciences Inc EFFICACY Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-5 Gilead Sciences Inc EFFICACY Approved
Hydrocodone Bitartrate and Homatropine Methylbromide
ANDA #205731
Homatropine Methylbromide; Hydrocodone Bitartrate Syrup; Oral ORIG-1 Paddock Llc Approved
Kazano
NDA #203414
Alogliptin Benzoate; Metformin Hydrochloride Tablet; Oral SUPPL-7 Takeda Pharms Usa LABELING Approved
Omnitrope
NDA #021426
Somatropin Recombinant Injectable; Injection SUPPL-22 Sandoz LABELING Approved
Siliq
BLA #761032
Brodalumab Injectable; Injection ORIG-1 Valeant Luxembourg TYPE 1 Approved
Spiriva Respimat
NDA #021936
Tiotropium Bromide Spray, Metered; Inhalation SUPPL-7 Boehringer Ingelheim EFFICACY Approved

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English