ANDA 205328, held by Actavis Labs Ut Inc. Testosterone.
As of Nov 14, 2026, ANDA 205328 (Testosterone), held by Actavis Labs Ut Inc, was first approved by FDA on Aug 7, 2017, with 3 approved supplements and 0 published complete response letters.
Testosterone topical solution is indicated for replacement therapy in 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 (FSH, LH) above the normal range.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone30MG/1.5ML ACTUATION · solution, metered;transdermal | Testosterone | Rx |
| Jul 15, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 11, 2019 | Supplement 2REMS | Approved | None posted |
| May 10, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 7, 2017 | Original application | Approved |
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
