TIZANIDINE HYDROCHLORIDE | N021447 | LEGACY PHARMA USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-0268 Senores Pharmaceuticals, Inc. submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Tizanidine Capsules, 3 mg, suitable for submission as an ANDA, with the reference listed drug being Covis Pharma B.V.'s ZANAFLEX capsu | Suitability | 2025-01-17 | Open | Senores Pharmaceuticals |
Attachment 2- Package Insert Zanaflex re Suitability Petition from Lachman Co... 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. | Suitability | 2023-10-05 | Open | Lachman Consultant Services |
Attachment 1-Orange Book listing Zanaflex re Suitability Petition from Lachma... 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 | Suitability | 2023-10-05 | Open | Lachman Consultant Services |
Suitability Petition from HYMAN PHELPS MCNAMARA P.C. FDA-2021-P-0495 Hyman, Phelps & McNamara P.C. filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tizanidine Capsules, 8 mg, suitable for submission as an Abbreviated New Drug Application, with Covis Pharma B.V.' | Suitability | 2021-05-24 | Open | HYMAN PHELPS MCNAMARA P.C. |
Attachment 2- HIGHLIGHTS OF PRESCRIBING INFORMATION for ZANAFLEX re Suitabili... 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. | Suitability | 2021-05-24 | Open | HYMAN PHELPS MCNAMARA P.C. |
Attachment 3 - TIZANIDINE HYDROCHLORIDE CAPSULES - tizanidine hydrochloride c... 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. | Suitability | 2021-05-24 | Open | HYMAN PHELPS MCNAMARA P.C. |
Citizen Petition from Acorda Therapeutics, Inc. 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 | Other | 2008-05-08 | Withdrawn | Acorda Therapeutics |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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