ESTRADIOL | A084500 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2259 Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Estradiol Tablets in 0.25 mg and 0.75 mg strengths suitable for ANDA submission, based on the reference listed drug | Suitability | 2026-03-04 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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