HYDROCORTISONE | A080442 | BAUSCH HEALTH AMERICAS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Epstein Becker & Green, P.C. FDA-2025-P-0441 · 4 docket documents Epstein Becker & Green, P.C., filed this citizen petition requesting that the FDA determine whether Nutracort (topical hydrocortisone gel 1%), approved under NDA N84698 and held by Healthpoint Ltd., was voluntarily withdrawn from the market for reasons of safety or effectiveness, as required under S | 505(q) | 2025-02-18 | Granted | Epstein Becker & Green, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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