ANDA 212882, held by Alembic. Testosterone.
As of Nov 14, 2026, ANDA 212882 (Testosterone), held by Alembic, was first approved by FDA on Jun 14, 2021, with 1 approved supplement 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 |
|---|---|---|---|
| Jun 14, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone30MG/1.5ML ACTUATION · solution, metered;transdermal | Testosterone | Discontinued |
| Jul 11, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 14, 2021 | 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
