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 · 7 docket documents 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 | Partially Denied | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Foley & Lardner, LLP FDA-2020-P-1878 · 4 docket documents Foley & Lardner LLP filed this citizen petition on behalf of an unnamed client under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Warfarin Sodium Tablets USP 10 mg held by Taro Pharmaceutical Industries Ltd. (ANDA No. 040301) as a suitable additional Re | Other | 2020-09-18 | Withdrawn | Foley & Lardner, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.