ANDA 76737, held by Actavis Labs Ut Inc. Testosterone.
As of Nov 14, 2026, ANDA 76737 (Testosterone), held by Actavis Labs Ut Inc, was first approved by FDA on Jan 27, 2006, with 4 approved supplements and 0 published complete response letters.
Testosterone gel 1% 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 |
|---|---|---|---|
| Jan 27, 2006 | Original application | Approved |
| Testosterone25MG/2.5GM PACKET · gel;transdermal | Testosterone | Rx |
| Testosterone50MG/5GM PACKET · gel;transdermal | Testosterone | Rx |
| Testosterone12.5MG/1.25GM ACTUATION · gel, metered;transdermal | Testosterone | Rx |
| Jun 3, 2019 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 3, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 5, 2015 | Supplement 6REMS | Approved | None posted |
| Oct 28, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 27, 2006 | 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
