TIZANIDINE HYDROCHLORIDE | N216190 | FIDELITY BIOPHARMA CO USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - TIZANIDINE HYDROCHLORIDE CAPSULES - tizanidine hydrochloride c... FDA-2021-P-0495 · 6 docket documents 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. | Suitability | 2021-05-24 | Granted | HYMAN PHELPS MCNAMARA P.C. |
Acorda Therapeutics, Inc. - Citizen Petition 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 | 505(q) | 2011-09-20 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition 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Tablets, 2 mg, approved under Acorda Therapeutics' NDA 20-397, were voluntarily withdra | 505(q) | 2009-04-23 | Withdrawn | — |
Citizen Petition from Acorda Therapeutics, Inc. 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arguing that the current listing creates patient safety risks by causing prescription substitu | Other | 2008-05-08 | Withdrawn | Acorda Therapeutics, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.