ANDA 208560, held by Lupin. Testosterone.
As of Nov 14, 2026, ANDA 208560 (Testosterone), held by Lupin, was first approved by FDA on Apr 10, 2019, with 1 approved supplement and 0 published complete response letters.
Testosterone gel 1.62% 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 gel 1.62% in men with "age-related hypogonadism" have not been established. Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established. ( 1, 8.4 ) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. ( 1, 12.3 ) Testosterone gel 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 10, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone1.62% (20.25MG/1.25GM ACTUATION) · gel, metered;transdermal | Testosterone | Rx |
| Jun 3, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 10, 2019 | 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
