ANDA 84219, held by Reed And Carnrick. Lindane.
As of Nov 13, 2026, ANDA 84219 (Kwell), held by Reed And Carnrick, was first approved by FDA on Jan 22, 1975, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kwell1% ยท shampoo;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
