Drugs
?
-
New and Generic Drug Approvals
Visit Drugs@FDA to Search Drug Approval Reports by Month
We have changed the format of this page. You will now find approvals listed under the date of the action, rather than the date we added the information to the website.
September 13, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Butalbital, Acetaminophen and Caffeine | acetaminophen; butalbital; caffeine | Tablet; Oral | Lannett Holdings Inc | Approval |
Increlex | mecasermin recombinant | Injectable; Subcutaneous | Ipsen Inc | Labeling Revision |
Prilosec Otc | omeprazole magnesium | Tablet, Delayed Release; Oral | Astrazeneca | Labeling Revision |
Uniretic | hydrochlorothiazide; moexipril hydrochloride | Tablet; Oral | Ucb Inc | Labeling Revision |
Vaseretic | enalapril maleate; hydrochlorothiazide | Tablet; Oral | Valeant Intl | Labeling Revision |
Vasotec | enalapril maleate | Tablet; Oral | Valeant Intl | Labeling Revision |
Voltaren | diclofenac sodium | Solution/Drops; Ophthalmic | Novartis | Labeling Revision |
September 12, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Aubagio | teriflunomide | Tablet; Oral | Sanofi Aventis Us | Approval |
Avapro | irbesartan | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
Choline C 11 | choline c 11 | Injectable; Injection | Mayo Clinic Mcprf | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Sti Pharma Llc | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Jubilant Organosys | Approval |
Olanzapine | olanzapine | Tablet, Orally Disintegrating; Oral | Jubilant Organosys | Approval |
Tarka | trandolapril; verapamil hydrochloride | Tablet, Extended Release; Oral | Abbott | Labeling Revision |
Teveten | eprosartan mesylate | Tablet; Oral | Abbott | Labeling Revision |
Teveten Hct | eprosartan mesylate; hydrochlorothiazide | Tablet; Oral | Abbott | Labeling Revision |
September 11, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Lupin Ltd | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Invagen Pharms | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Hikma Pharms | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Apotex Inc | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Torrent Pharms Ltd | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Macleods Pharms Ltd | Approval |
Escitalopram Oxalate | escitalopram oxalate | Tablet; Oral | Accord Hlthcare | Approval |
Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable; Injection | Emcure Pharms Ltd | Approval |
Mavik | trandolapril | Tablet; Oral | Abbott | Labeling Revision |
September 10, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Gemcitabine | gemcitabine | Injectable; Injection | Hameln Rds Gmbh | Approval |
Omeprazole | omeprazole | Tablet, Delayed Release; Oral | Dexcel Pharma | Approval |
Zyrtec Allergy | cetirizine hydrochloride | Tablet; Oral | Mcneil Consumer | Labeling Revision |
Zyrtec Hives Relief | cetirizine hydrochloride | Tablet; Oral | Mcneil Consumer | Labeling Revision |
September 7, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Aggrenox | aspirin; dipyridamole | Capsule, Extended Release; Oral | Boehringer Ingelheim | Labeling Revision |
Androgel | testosterone | Gel, Metered; Transdermal | Abbott Labs | Labeling Revision |
Clobex | clobetasol propionate | Spray; Topical | Galderma Labs Lp | Labeling Revision |
Levofloxacin | levofloxacin | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
Multaq | dronedarone hydrochloride | Tablet; Oral | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
Multaq | dronedarone hydrochloride | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
Ozurdex | dexamethasone | Implant; Intravitreal | Allergan | Labeling Revision |
Xopenex | levalbuterol hydrochloride | Solution; Inhalation | Sunovion | Labeling Revision |
September 6, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Bicillin C-R | penicillin g benzathine; penicillin g procaine | Injectable; Injection | King Pharms | Labeling Revision |
Bicillin C-R 900/300 | penicillin g benzathine; penicillin g procaine | Injectable; Injection | King Pharms | Labeling Revision |
Bicillin L-A | penicillin g benzathine | Injectable; Injection | King Pharms | Labeling Revision |
Cefepime and Dextrose In Duplex Container | cefepime hydrochloride | Injectable; Injection | B Braun | Labeling Revision |
Cefepime In Plastic Container | cefepime hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
Leucovorin Calcium Preservative Free | leucovorin calcium | Injectable; Injection | Sagent Pharms | Approval |
Leucovorin Calcium Preservative Free | leucovorin calcium | Injectable; Injection | Sagent Pharms | Approval |
Maxipime | cefepime hydrochloride | Injectable; Injection | Hospira Inc | Labeling Revision |
Tramadol Hydrochloride and Acetaminophen | acetaminophen; tramadol hydrochloride | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
Ventolin Hfa | albuterol sulfate | Aerosol, Metered; Inhalation | Glaxosmithkline | Labeling Revision |
Xyzal | levocetirizine dihydrochloride | Tablet; Oral | Ucb Inc | Labeling Revision |
Xyzal | levocetirizine dihydrochloride | Solution; Oral | Ucb Inc | Labeling Revision |
September 5, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Amlodipine Besylate and Benazepril Hydrochloride | amlodipine besylate; benazepril hydrochloride | Capsule; Oral | Aurobindo Pharma Ltd | Approval |
Declomycin | demeclocycline hydrochloride | Tablet; Oral | Corepharma | Labeling Revision |
Trilipix | choline fenofibrate | Capsule, Delayed Release; Oral | Abbott Labs | Labeling Revision |
Trilipix | choline fenofibrate | Capsule, Delayed Release; Oral | Abbott Labs | Manufacturing Change or Addition |
Ziprasidone Hydrochloride | ziprasidone hydrochloride | Capsule; Oral | Wockhardt Ltd | Approval |
September 4, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Aricept | donepezil hydrochloride | Tablet; Oral | Eisai Inc | Labeling Revision |
Aricept | donepezil hydrochloride | Tablet; Oral | Eisai Inc | Labeling Revision |
Aricept Odt | donepezil hydrochloride | Tablet, Orally Disintegrating; Oral | Eisai Inc | Labeling Revision |
Bosulif | bosutinib | Tablet; Oral | Wyeth Pharms Inc | Approval |
Children's Advil | ibuprofen | Suspension; Oral | Wyeth Cons | Manufacturing Change or Addition |
Children's Advil-Flavored | ibuprofen | Suspension; Oral | Wyeth Cons | Manufacturing Change or Addition |
Lovaza | omega-3-acid ethyl esters | Capsule; Oral | Smithkline Beecham | Labeling Revision |
-
-