ANDA 88190, held by Wockhardt Bio AG. Lindane.
As of Nov 14, 2026, ANDA 88190 (Lindane), held by Wockhardt Bio AG, was first approved by FDA on Aug 16, 1984, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lindane1% ยท lotion;topical | Lindane | Discontinued |
| Apr 12, 2005 | Supplement 24Labeling | Approved | None posted |
| Mar 27, 1997 | Supplement 20Labeling | Approved | None posted |
| Jun 30, 1995 | Supplement 19Labeling | Approved | None posted |
| Aug 2, 1994 | Supplement 18Labeling | Approved | None posted |
| Feb 8, 1994 | Supplement 17Manufacturing | Approved | None posted |
| May 29, 1990 | Supplement 16Manufacturing | Approved | None posted |
| Oct 10, 1989 | Supplement 15Labeling | Approved | None posted |
| Apr 5, 1989 | Supplement 14Manufacturing | Approved | None posted |
| Aug 10, 1988 | Supplement 13Manufacturing | Approved | None posted |
| Jan 28, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Jul 16, 1987 | Supplement 9Manufacturing | Approved | None posted |
| Jul 16, 1987 | Supplement 8Manufacturing | Approved | None posted |
| Jul 16, 1987 | Supplement 4Manufacturing | Approved | None posted |
| Jul 16, 1987 | Supplement 3Manufacturing | Approved | None posted |
| Jun 15, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Aug 11, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Sep 25, 1984 | Supplement 1Manufacturing | Approved | None posted |
| Aug 16, 1984 | 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
