TESTOSTERONE CYPIONATE | A040615 | CAPLIN ONE LABS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from BPI Labs, LLC FDA-2025-P-2525 BPI Labs, LLC filed an amendment to suitability petition FDA-2025-P-2525 seeking permission to file an ANDA for Testosterone Cypionate Injection, USP 200 mg/mL, and in response to an FDA information request, submitted proposed product labeling (package inserts) for the drug pursuant to 21 CFR 314.93 | Suitability | 2025-08-07 | Granted | BPI Labs, LLC |
Suitability Petition from BPI Labs, LLC FDA-2025-P-2525 BPI Labs, LLC submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting a determination that an additional pack size of 2.5 mL (500 mg fill) for Testosterone Cypionate Injection, USP 200 mg/mL is suitable for ANDA submission, arguing the new intermedia | Suitability | 2025-07-21 | Granted | BPI Labs, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.