TROKENDI XR

FDA-2023-P-4295

Newcastle Bioscience, LLC filed a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an ANDA for Topiramate Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, and 200 mg. The FDA determined the petition complete and assigned an April 12, 2024 goal date f

FDA-2023-P-4295

Newcastle Bioscience, LLC filed a Citizen Petition seeking FDA confirmation that Topamax (topiramate) tablets by Janssen is a suitable reference-listed drug for purposes of establishing bioequivalence in generic drug applications. The petition requests that the FDA designate this product as appropri

FDA-2023-P-4295

Newcastle Bioscience LLC filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Topiramate Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, and 200 mg suitable for submission as an ANDA, with the reference-listed

FDA-2023-P-4295

Newcastle Bioscience, LLC filed a petition regarding topiramate orally disintegrating tablets, requesting FDA review and approval of a draft insert label for this formulation as part of a suitability petition process.

FDA-2016-P-4141

Hyman, Phelps & McNamara, P.C., on behalf of Upsher-Smith Laboratories, Inc., requested that the FDA assign a therapeutic equivalence evaluation code of BC to Upsher-Smith's QUDEXY XR (topiramate) extended-release capsules in four strengths (25, 50, 100, and 200 mg) approved under NDA 205122 pursuan

FDA-2012-P-0764

The Joseph Dedvukaj Firm, P.C., a consumer advocacy law firm, filed this citizen petition on July 12, 2012, requesting that the FDA reject or issue a Complete Response Letter to Vivus' New Drug Application for Qnexa (phentermine and topiramate combination) for obesity, citing insufficient safety dat

FDA-2012-P-0738

The Joseph Dedvukaj Firm, P.C., a consumer advocacy law firm, filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA reject or issue a Complete Response Letter for Vivus' New Drug Application for Qnexa, an obesity drug candidate containing phentermine and topiramate, due to seri

FDA-2011-P-0931

Upsher-Smith Laboratories, Inc., filed this petition under section 505 of the Food, Drug, and Cosmetic Act requesting that FDA refrain from approving any new drug application for extended-release topiramate that does not include adequate and well-controlled safety and efficacy studies on the applica