PROGESTERONE | N019781 | ACERTIS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2353 Hyman, Phelps & McNamara, P.C. filed this amended suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Progesterone Tablets, 150 mg, suitable for submission as an Abbreviated New Drug Application, with the Reference Listed D | Suitability | 2026-04-06 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2353 Hyman, Phelps & McNamara, P.C., filed this Suitability Petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Progesterone Tablets in 150 mg and 300 mg strengths suitable for submission as an Abbreviated New Drug Ap | Suitability | 2026-03-06 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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