TIZANIDINE HYDROCHLORIDE | N021447 | LEGACY PHARMA USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-0754 · 8 docket documents 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 | Suitability | 2025-04-09 | Denied | Senores Pharmaceuticals, Inc. |
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-0268 · 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 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 | Granted | Senores Pharmaceuticals, Inc |
Attachment 1-Orange Book listing Zanaflex re Suitability Petition from Lachma... FDA-2023-P-4329 · 8 docket documents 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 | Denied | Lachman Consultant Services, Inc |
Suitability Petition from HYMAN PHELPS MCNAMARA P.C. FDA-2021-P-0495 · 6 docket documents 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 | 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.
Highest NADAC/Unit
$0.1270
per ea
Lowest NADAC/Unit
$0.0918
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00591279086TIZANIDINE HCL 6 MG CAPSULE | $0.1270 | EA | Generic | — | 2026-06-17 |
| 00591278886TIZANIDINE HCL 2 MG CAPSULE | $0.0931 | EA | Generic | — | 2026-06-17 |
| 00591278986TIZANIDINE HCL 4 MG CAPSULE | $0.0918 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.