ANDA 208061, held by Lupin. Testosterone.
As of Nov 14, 2026, ANDA 208061 (Testosterone), held by Lupin, was first approved by FDA on Oct 23, 2017, with 4 approved supplements and 0 published complete response letters.
Testosterone topical solution USP is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) Hypogonadotropic hypogonadism (congenital or acquired) Limitations of use: Safety and efficacy of testosterone topical solution USP in men with "age-related hypogonadism" have not been established. Safety and efficacy of testosterone topical solution USP in males <18 years old have not been established
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone30MG/1.5ML ACTUATION · solution, metered;transdermal | Testosterone | Rx |
| Jul 11, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jan 29, 2020 | Supplement 4Manufacturing | Approved | None posted |
| Jun 4, 2019 | Supplement 2REMS | Approved | None posted |
| May 10, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 23, 2017 | 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
