ANDA 212301, held by Encube. Testosterone.
As of Nov 14, 2026, ANDA 212301 (Testosterone), held by Encube, was first approved by FDA on Jan 11, 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 concentrations and gonadotropins (FSH, LH) above the normal range.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone30MG/1.5ML ACTUATION · solution, metered;transdermal | Testosterone | Rx |
| Jul 11, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 11, 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
