TESTOSTERONE CYPIONATE | A040530 | PADAGIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from BPI Labs, LLC FDA-2025-P-2525 · 8 docket documents 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.
Highest NADAC/Unit
$11.03
per ml
Lowest NADAC/Unit
$3.46
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00574082001TESTOSTERONE CYP 200 MG/ML | $11.03 | ML | Generic | — | 2026-06-17 |
| 00574082010TESTOSTERONE CYP 2,000 MG/10 ML | $3.46 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.