HYDROCORTISONE | A083231 | LEGACY PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Epstein Becker Green FDA-2025-P-1070 · 8 docket documents Attorneys at Epstein Becker & Green, P.C., through James A. Boiani, filed this amended suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine hydrocortisone topical gel 2.5% is suitable for submission in an Abbreviated New Drug A | Suitability | 2025-04-24 | Granted | Epstein Becker Green |
Suitability Petition from Epstein Becker & Green P. C. FDA-2025-P-0478 · 7 docket documents Epstein Becker & Green, P.C. filed this suitability petition requesting that the FDA determine hydrocortisone topical gel 2% is suitable for submission as an Abbreviated New Drug Application, with the listed drug being ALA-Scalp (hydrocortisone lotion USP 2%) approved under ANDA 083-231, representin | Suitability | 2025-02-21 | Granted | Epstein Becker & Green P. C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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