For unwashed or unclothed application sites. ANDA 209390, held by Twi Pharms. Testosterone.
As of Nov 14, 2026, ANDA 209390 (Testosterone), held by Twi Pharms, was first approved by FDA on Sep 23, 2019, with 1 approved supplement and 0 published complete response letters.
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to testosterone gel ( 5.2, 6.2 ). Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel ( 2.2, 5.2 ). Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2, 5.2, 17 ). Testosterone gel 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Testosterone1.62% (20.25MG/1.25GM ACTUATION) · gel, metered;transdermal | Testosterone | Discontinued |
| Sep 15, 2026 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 23, 2019 | 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
