ANDA 91120, held by Hikma Farmaceutica. Testosterone Enanthate.
As of Nov 13, 2026, ANDA 91120 (Testosterone Enanthate), held by Hikma Farmaceutica, was first approved by FDA on Sep 18, 2012, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Males Testosterone Enanthate Injection, USP 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 |
|---|---|---|---|
| Sep 18, 2012 | 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 10Labeling · Standard review | Approved | None posted |
| Oct 29, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 8, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 21, 2014 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 18, 2012 | 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
