TESTOSTERONE ENANTHATE | A091120 | HIKMA FARMACEUTICA PORTUGAL SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Xiromed, LLC. FDA-2025-P-1085 · 8 docket documents 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 | Granted | Xiromed, LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$14.76
per ml
Lowest NADAC/Unit
$14.76
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00143975001TESTOSTERON ENAN 1,000 MG/5 ML | $14.76 | 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.