ZANAFLEX

FDA-2025-P-5492

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

Senores Pharmaceuticals, Inc. filed an amendment to its suitability petition (FDA-2025-P-0754) seeking FDA permission to file an ANDA for Tizanidine Sublingual Tablets, 2 mg, a change in route of administration from the approved Zanaflex formulation. The petitioner requested a waiver from pediatric

FDA-2025-P-0754

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

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-4329

Lachman Consultant Services, Inc. filed a petition regarding Orange Book listing for Zanaflex, requesting a determination of suitability for abbreviated new drug application (ANDA) eligibility or related regulatory classification for the tizanidine product. The petition sought FDA clarification on t

FDA-2023-P-4329

Lachman Consultant Services, Inc. filed a citizen petition regarding the package insert for Zanaflex, a drug product, requesting that the FDA review and approve modifications or updates to the product's labeling to ensure its suitability and compliance with current regulatory standards.

FDA-2023-P-4285

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

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-2021-P-0495

Hyman Phelps McNamara P.C. filed a suitability petition regarding tizanidine hydrochloride capsules, requesting FDA evaluation of the product's suitability for approval as an ANDA or NDA, though the specific requested action is not detailed in the provided text.

FDA-2013-P-0847

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

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

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

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