ANDA 210835, held by Xiromed. Testosterone.
As of Nov 14, 2026, ANDA 210835 (Testosterone), held by Xiromed, was first approved by FDA on Apr 16, 2020, with 0 approved supplements 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 16, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone1.62% (20.25MG/1.25GM ACTUATION) · gel, metered;transdermal | Testosterone | Rx |
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
