METAXALONE | A203399 | AMNEAL PHARMACEUTICALS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-5590 · 11 docket documents 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 | Denied | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3926
per ea
Lowest NADAC/Unit
$0.3926
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 65162055310METAXALONE 800 MG TABLET | $0.3926 | EA | Generic | — | 2026-06-17 |
| 50268053015METAXALONE 800 MG TABLET | $0.3926 | 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.