ANDA 91073, held by Actavis Labs Ut Inc. Testosterone.
As of Nov 14, 2026, ANDA 91073 (Testosterone), held by Actavis Labs Ut Inc, was first approved by FDA on Sep 18, 2017, with 3 approved supplements and 0 published complete response letters.
Testosterone gel 1% is indicated for testosterone 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 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 |
|---|---|---|---|
| Sep 18, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone50MG/5GM PACKET · gel;transdermal | Testosterone | Rx |
| Feb 7, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 7, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 21, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 18, 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
