TOPAMAX

FDA-2023-P-4295 · 7 docket documents

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-2022-P-1939 · 4 docket documents

Hyman, Phelps & McNamara, P.C. filed this petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether TOPAMAX (topiramate capsules) Sprinkle Capsules, 50 mg, approved under NDA 020844 and held by Janssen Pharmaceuticals, Inc.,

FDA-2021-P-0674 · 6 docket documents

On behalf of a client, the law firm Hyman, Phelps & McNamara, P.C. filed a Suitability Petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Topiramate Capsules in 75 mg, 100 mg, 125 mg, 150 mg, and 200 mg strengths suitable for submission in

FDA-2012-P-0764 · 3 docket documents

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 · 3 docket documents

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 · 6 docket documents

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