ANDA 84989, held by Sola Barnes Hind. Lindane.
As of Nov 14, 2026, ANDA 84989 (Gamene), held by Sola Barnes Hind, was first approved by FDA on Jun 15, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gamene1% ยท lotion;topical | Lindane | Discontinued |
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
