New and Generic Drug Approvals
Atacand HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca LP, Formulation Revision
Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
Geodon (ziprasidone mesylate) Injection, Pfizer, Inc., Labeling Revision
ganisetron hydrochloride (Kytril) Injection, Wockhardt USA, Inc., Tentative Approval
hydrochlorothiazide Capsules, Apotex Corp., Approval
Invega (paliperidone) Extended-Release Tablets, Janssen LP, Labeling Revision
Keppra (levetiracetam) Injection, UCB, Inc., New or Modified Indication
Levitra (vardenafil hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
metoprolol succinate Extended-Release Tablets, KV Pharmaceutical Co., Approval
mitoxantrone hydrochloride (Novantrone) Injection, Dabur Oncology, Plc., Approval
Mycobutin (rifabutin) Capsules, Pharmacia and Upjohn Co., Labeling Revision
Nevirapine Tablets, Matrix Laboratories, Ltd., Tentative Approval
topiramate Capsules, Cobalt Laboratories, Inc., Tentative Approval
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