TESTOSTERONE ENANTHATE | A091120 | HIKMA FARMACEUTICA PORTUGAL SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Xiromed, LLC. FDA-2025-P-1085 Xiromed Pharma Espana SL filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that FDA declare Testosterone Enanthate Injection, USP 400 mg/2 mL (200 mg/mL) as a pre-filled syringe suitable for submission as an ANDA, | Suitability | 2025-04-15 | Open | Xiromed |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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