ANDA 204851, held by Impax Labs Inc. Methyltestosterone.
As of Nov 14, 2026, ANDA 204851 (Methyltestosterone), held by Impax Labs Inc, was first approved by FDA on Sep 21, 2015, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 1. Males Androgens are 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 torsions, 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 21, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methyltestosterone10MG · capsule;oral | Methyltestosterone | Rx |
| Jul 11, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 25, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 21, 2015 | 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
