ZANAFLEX

FDA-2025-P-5492 · 7 docket documents

Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act and 21 C.F.R. § 314.93 requesting FDA approval to submit an ANDA for Tizanidine Tablets in 3 mg and 6 mg strengths, which differ from the Reference Listed Drug Zanaflex (approved in 2 mg and 4 mg

FDA-2025-P-0754 · 8 docket documents

Senores Pharmaceuticals, Inc. submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to file an ANDA for Tizanidine Sublingual Tablet, 2 mg, which differs in route of administration from the reference listed drug ZANAFLEX (tizan

FDA-2023-P-4329 · 8 docket documents

Lachman Consultant Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Tizanidine Orally Disintegrating Tablets in 2 mg and 4 mg strengths as a new dosage form based on the RLD ZANAFLEX Tab

FDA-2023-P-4285 · 7 docket documents

Newcastle Bioscience LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Tizanidine Hydrochloride Tablets, 8 mg, suitable for submission as an ANDA, with Zanaflex Tablets, 4 mg (NOA 020397) as the reference listed

FDA-2021-P-0495 · 6 docket documents

Hyman Phelps McNamara P.C. filed a suitability petition regarding Zanaflex (tizanidine), a muscle relaxant, requesting FDA evaluation of the drug's suitability for approval or authorization under applicable regulatory pathways.

FDA-2013-P-0847 · 3 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tizanidine Hydrochloride Tablets, 8 mg, suitable for submission as an abbreviated new drug application, representing

FDA-2011-P-0654 · 6 docket documents

Acorda Therapeutics, Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act on September 6, 2011, requesting that the FDA disapprove Apotex's ANDA No. 78-868 for generic tizanidine hydrochloride capsules citing Acorda's Zanaflex Capsules as the reference liste

FDA-2009-P-0194 · 3 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client pursuant to 21 CFR 10.30 and 314.161, requesting that the FDA Commissioner determine whether Zanaflex (Tizanidine Hydrochloride) Tablets, 2 mg, approved under Acorda Therapeutics' NDA 20-397, were voluntarily withdra

FDA-2007-P-0189 · 14 docket documents

Acorda Therapeutics, Inc. filed this petition requesting that the FDA incorporate the full proprietary name "Zanaflex Capsules" in the Orange Book instead of the truncated form "Zanaflex" under NDA 21-447, arguing that the current listing creates patient safety risks by causing prescription substitu