METAXALONE | A203399 | AMNEAL PHARMACEUTICALS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-5590 Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Metaxalone Tablets 600 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being SKELAXIN (M | Suitability | 2023-12-19 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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