GANIRELIX ACETATE | N021057 | ORGANON USA LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-1161 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA declaration that Ganirelix Acetate Injection 1.5 mg/3 mL in an autoinjector pen is suitable for ANDA submission as a new strength compared to the ref | Suitability | 2025-05-09 | Open | Lachman Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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