ANDA 207373, held by Amneal. Testosterone.
As of Nov 14, 2026, ANDA 207373 (Testosterone), held by Amneal, was first approved by FDA on Apr 10, 2019, with 1 approved supplement and 0 published complete response letters.
Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 10, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone1.62% (20.25MG/1.25GM ACTUATION) · gel, metered;transdermal | Testosterone | Rx |
| Jun 21, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 10, 2019 | 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
