METAXALONE | A040486 | MOUNTAIN LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sovereign Pharmaceuticals, LLC FDA-2016-P-2342 Sovereign Pharmaceuticals, LLC filed an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Metaxalone 400 mg and 640 mg tablets, seeking in-vivo bioequivalence testing waivers based on bioequivalence studies using the 800 mg referenc | Other | 2016-08-01 | Withdrawn | Sovereign Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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