FDA Approves ANDA079162 for Topiramate Generic Tablets

The U.S. Food and Drug Administration (FDA) has granted approval for application number ANDA079162, covering generic topiramate tablets intended for oral administration. The approved products are prescription‑only tablets available in four strengths: 25 mg, 50 mg, 100 mg, and 200 mg. Two manufacturers are listed on the approval: Cipla USA Inc. and Exelan Pharmaceuticals Inc. All products are classified as human prescription drugs and are marketed under the brand name TOPIRAMATE. The dosage form for each product is a tablet, and the route of administration is oral. The FDA’s submission record shows multiple labeling submissions associated with this ANDA. Notable submission dates include a labeling submission on 27 January 2010 (submission number 1) and two labeling submissions dated 24 April 2026 (submission numbers 13 and 26). All submissions were reviewed under standard priority and received an “AP” (Approved) status.