ANDA 212984, held by Encube. Testosterone.
As of Nov 14, 2026, ANDA 212984 (Testosterone), held by Encube, was first approved by FDA on Nov 9, 2021, with 1 approved supplement 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 |
|---|---|---|---|
| Nov 9, 2021 | Original application | Approved | None posted |
| Testosterone50MG/5GM PACKET · gel;transdermal | Testosterone | Rx |
| Testosterone12.5MG/1.25GM ACTUATION · gel, metered;transdermal | Testosterone | Rx |
| Testosterone25MG/2.5GM PACKET · gel;transdermal | Testosterone | Rx |
| Dec 17, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 9, 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
