ANDA 212659, held by Eugia Pharma. Testosterone Enanthate.
As of Nov 13, 2026, ANDA 212659 (Testosterone Enanthate), held by Eugia Pharma, was first approved by FDA on Feb 28, 2024, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Males Testosterone enanthate injection is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) – Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) – Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone Enanthate200MG/ML · injectable;injection | Testosterone Enanthate | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 28, 2024 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
