HYDROCORTISONE | N009864 | PHARMACIA AND UPJOHN CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma LLC FDA-2026-P-3242 · 6 docket documents Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Hydrocortisone Tablets USP in 2.5 mg and 7.5 mg strengths, which differ from the currently approved Referen | Suitability | 2026-03-27 | Open | Appco Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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