EZETIMIBE; SIMVASTATIN | N021687 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps, & McNamara P.C. FDA-2026-P-5995 Hyman, Phelps & McNamara P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Ezetimibe and Simvastatin Tablets in 10 mg/15 mg and 10 mg/30 mg strengths suitable for submission as an ANDA | Suitability | 2026-05-28 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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