WARFARIN SODIUM | N009218 | BRISTOL MYERS SQUIBB PHARMA CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-5808 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Warfarin Sodium Oral Solution in 1 mg/mL and 2.5 mg/mL strengths suitable for sub | Suitability | 2024-12-17 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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