HYDROCORTISONE | A080425 | MISSION PHARMACAL CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Epstein Becker Green FDA-2025-P-1070 · 8 docket documents Epstein Becker & Green, P.C., filed this suitability petition under Federal Food, Drug, and Cosmetic Act Section 505(j)(2)(C) requesting that the FDA determine hydrocortisone topical gel 2.5% suitable for submission as an Abbreviated New Drug Application, with the listed drug being Texacort (hydroco | Suitability | 2025-04-09 | Granted | Epstein Becker Green |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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