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Drugs
New and Generic Drug Approvals
Visit Drugs@FDA to search Drug Approval Reports by Month.
August 20, 2010
- Atazanavir Sulfate Capsules, Emcure Pharmaceuticals, Ltd., Tentative Approval
- Flagyl (metronidazole) Tablets, Pfizer, Inc., Labeling Revision
- Flagyl (metronidazole) Capsules, Pfizer, Inc., Labeling Revision
- Flagyl ER (metronidazole) Extended-Release Tablets, Pfizer, Inc., Labeling Revision
- Losartan Potassium and Hydrochlorothiazide Tablets, Sandoz, Inc., Approval
August 19, 2010
- Duloxetine Hydrochloride Delayed-Release Capsules, Torrent Pharmaceuticals Ltd., Tentative Approval
- Fludeoxyglucose F-18 Injection, Feinstein Institute for Medical Research, Labeling Revision
- Venlafaxine Hydrochloride Extended-Release Tablets, Sun Pharmaceutical Industries, Inc., Approval
August 18, 2010
- Ampicillin for Injection, Aurobindo Pharma Limited, Approval
- Donepezil Hydrochloride Tablets, Pliva Hrvatska d.o.o., Tentative Approval
- Gemfibrozil Tablets, Hikma Pharmaceuticals, Approval
- Plavix (clopidogrel bisulfate) Tablets, Sanofi-aventis, Labeling Revision
- ProAir HFA (albuterol sulfate) Inhalation Aerosol, Teva Branded Pharmaceuticals, Labeling Revision
August 17, 2010
- Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Labeling Revision
- Aptivus (tipranavir) Oral Soultion, Boehringer Ingelheim Pharmaceuticals, Labeling Revision
- Biltricide (praziquantel) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Gemfibrozil Tablets, Hikma Pharmaceuticals, Approval
August 13, 2010
- Aleve (naproxen sodium) Capsules, Banner Pharmacaps, Inc., Labeling Revision
- Amerge (naratriptan hydrochloride) Tablets, GlazoSmithKline, Approval
- Creon (pancrelipase) Delayed-Release Capsules, Abbott Laboratories, Labeling Revision
- Imitrex (sumatriptan succinate) Tablets, GlaxoSmithKline, Labeling Revision
- Isosorbide Mononitrate Extended-Release Tablets, Vintage Pharmaceuticals, LLC, Approval
- Losartan Potassium Tablets, Apotex, Inc., Tentative Approval
- Maxalt (rizatriptan benzoate) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
- Maxalt-MLT (rizatriptan benzoate) Orally Disintegrating Tablets, Merck Sharp & Dohme Corp., Labeling Revision
- Sumatriptan Succinate Subcutaneous Injection, Bedford Laboratories, Approval
- Zithromax (azithromycin) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
- Zithromax (azithromycin) Tablets, Pfizer Global Research and Development, Labeling Revision
- Zithromax (azithromycin) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
- Zithromax (azithromycin) Tablets, Pfizer Global Research and Development, Labeling Revision
- Zithromax (azithromycin) Tablets, Pfizer Global Research and Development, Labeling Revision
- Zithromax (azithromycin) Injection, Pfizer Global Research and Development, Labeling Revision
- Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets, AstraZeneca Pharmaceuticals, Approval
- Zomig (zolmitriptan) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
August 12, 2010
- Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets, Takeda Pharmaceuticals, Labeling Revision
- Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision
- Losartan Potassium and Hydrochlorothiazide Tablets, Apotex, Inc., Approval
- Ranitidine Hydrochloride Syrup, Aurobindo Pharma, Approval
- Risperidone Orally Disintegrating Tablets, Ranbaxy Laboratories Limited, Approval
- Singulair (montelukast sodium) Tablets, Merck and Co., Inc., Labeling Revision
August 11, 2010
- Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
- Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer, Inc., Labeling Revision
- Diflucan (fluconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
- Levetiracetam Tablets, Orchid Healthcare, Approval
- Meridia (sibutramine hydrochloride) Capsules, Abbott Laboratories, Labeling Revision
- Ondansetron Hydrochloride Injection, Lannett Holdings, Inc., Approval
- Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Suspension, Braintree Laboratories, Inc., Approval
- Tekturna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision
- Valcyte (valganciclovir hydrochloride) Tablets, Hoffmann-La Roche Inc., Efficacy Supplement and Labeling Revision
- Valturna (aliskiren hemifumarate and valsartan) Tablets, Novartis Pharmaceuticals, Labeling Revision
- Venlafaxine Hydrochloride Tablets, Vintage Pharmaceuticals, Approval
August 10, 2010
- Letrozole Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval
- Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
August 9, 2010
- Altavera (levonorgestrel and ethinyl estradiol) Tablets, Sandoz Inc., Approval
- Brimonidine Tartrate Ophthalmic Solution, Alcon Research, Ltd., Labeling Revision
- Clotrimazole Topical Cream, Glenmark Generics Inc., Approval
- Famotidine Tablets, Wockhardt Ltd., Approval
- Epzicom (abacavir sulfate and lamivudine) Tablets, ViiV Healthcare Company, Supplement
- Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, ViiV Healthcare Company, Supplement
- Ziagen (abacavir sulfate) Oral Solution, ViiV Healthcare Company, Supplement
- Ziagen (abacavir sulfate) Tablets, ViiV Healthcare Company, Supplement
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