November 17, 2010
- Byetta (exenatide synthetic) Subcutaneous Injection, Amylin Pharmaceuticals, Inc., Labeling Revision
- Diltiazem Hydrochloride Extended-Release Capsules, Sun Pharmaceutical, Approval
- Finasteride Tablets, Accord Healthcare, Tentative Approval
- Gemcitabine Injection, Hospira, Inc., Approval
- Indomethacin Capsules, Zydus Pharmaceuticals, Approval
- Ranitidine Hydrochloride (Zantac) Syrup, Tolmar Inc., Approval
- Rifater (rifampin, isoniazid and pyrazinamide), Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision
- Ritalin (methylphenidate hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Ritalin-SR (methylphenidate hydrochloride) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
- Rocephin (ceftriaxone sodium) Intramuscular I.V. Injection , Hoffmann-La Roche Inc., Labeling Revision
- Synercid (quinupristin and dalfopristin) Injection, King Pharmaceuticals, Inc., Labeling Revision
- Xifaxan (rifaximin) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
November 15, 2010
- Adderall XR (amphetamine aspartate, amphetamine sulfate, dextroamphetamine sacchrate and dextroamphetamine sulfate) Capsules, Shire Development Inc., Labeling Revision
- Cyclafem 1/35 (norethindrone and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval
- Emend (fosaprepitant dimeglumine) Intravenous Powder, Merck, Efficacy Supplement
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Inc., Tentative Approval
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Approval
- Septocaine (articaine hydrochloride and epinephrine bitartrate) Injection, Deproco, Inc., Labeling Revision
November 12, 2010
- Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser, Inc., Manufacturing Change or Addition
- Egrifta (tesamorelin) Injection, Kendle International, Inc., Approval
- Kombiglyze (saxagliptin and metformin hydrochloride) Extended-Release Tablets, Bristol-Myers Squibb Co., Approval
- Niaspan (niacin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
- Olux-E (clobetasol propionate) Foam, Stiefel Laboratories, Inc., Labeling Revision
- Restoril (temazepam) Capsules, Mallinckrodt, Inc., Labeling Revision
- Rifadin (rifampin) Capsules, sanofi-aventis U.S., LLC, Labeling Revision
- Rifadin (rifampin) Injection, sanofi-aventis U.S., LLC, Labeling Revision
- Rozerem (ramelteon) Tablets, Takeda Global Research and Development Center, Inc., Labeling Revision
- Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Pharmaceuticals, Inc., Labeling Revision
November 9, 2010
- Banzel (rufinamide) Tablets, Eisai Medical Research, Inc., Labeling Revision
- Cedax (ceftibuten dihydrate) Capsules, Pernix Therapeutics, LLC, Labeling Revision
- Cedax (ceftibuten dihydrate) Oral Suspension, Pernix Therapeutics, LLC, Labeling Revision
- Duac (benzoyl peroxide and clindamycin) Gel, Stiefel Laboratories, Inc., Approval
- E.E.S (erythromycin ethylsuccinate) Oral Granules, Abbott Laboratories, Labeling Revision
- Eraxis (anidulafungin) I.V. Injection, Vicuron Holdings LLC, a subsidiary of Pfizer, Inc., Labeling Revision
- Eryped (erythromycin ethylsuccinate) Chewable Tablets, Abbott Laboratories, Labeling Revision
- Levetiracetam Tablets, BioKey, Inc., Approval
- Metopirone (metyrapone) Capsules, Novartis Pharmaceuticals, Labeling Revision
- PCE (erythromycin) Tablets, Abbott Laboratories, Labeling Revision
- Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche Inc., Labeling Revision
- Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche Inc., Labeling Revision
- Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision
November 5, 2010
- Aleve (naproxen sodium) Tablets, Bayer HealthCare, LLC, Labeling Revision
- Cymbalta (duloxetine hydrochloride) Capsules, Eli Lilly & Co., Approval
- Flovent HFA (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
- Ofirmev (acetaminophen) injection, Cadence Pharmaceuticals, Approval
November 4, 2010
- Metformin Hydrochloride Tablets, Alkem Laboratories, Ltd., Approval
- MoviPrep (sodium sulfate, sodium chloride, sodium ascorbate, potassium chloride, polyethylene glycol 3500 and ascorbic acid), Oral Solution, Salix Pharmaceuticals, Inc., Labeling Revision
- Prednisone Tablets, West-Ward Pharmaceutical Corp., Approval
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