TESTOSTERONE CYPIONATE | A085635 | PFIZER INC
| 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 | GrantedNo FDA response document on docket | BPI Labs, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.55
per ml
Lowest NADAC/Unit
$3.65
per ml
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00409656201TESTOSTERONE CYP 200 MG/ML | $11.55 | ML | Generic | — | 2026-08-19 |
| 00009034702DEPO-TESTOSTERONE 1,000 MG/10 ML | $6.92 | ML | — | $5.00 | 2025-12-17 |
| 00009008510DEPO-TESTOSTERONE 1,000 MG/10 ML | $6.92 | ML | — | $5.00 | 2025-12-17 |
| 00409655701TESTOSTERONE CYP 1,000 MG/10 ML | $5.00 | ML | Generic | — | 2026-08-19 |
| 00409656220TESTOSTERONE CYP 2,000 MG/10 ML | $3.65 | ML | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.