TIZANIDINE HYDROCHLORIDE | A076280 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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arguing that the current listing creates patient safety risks by causing prescription substitu | Other | 2008-05-08 | Withdrawn | Acorda Therapeutics |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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