ANDA 88191, held by Wockhardt Bio AG. Lindane.
As of Nov 14, 2026, ANDA 88191 (Lindane), held by Wockhardt Bio AG, was first approved by FDA on Sep 18, 1984, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lindane1% ยท shampoo;topical | Lindane | Discontinued |
| Aug 22, 2007 | Supplement 25Labeling | Approved | None posted |
| Mar 27, 1997 | Supplement 22Labeling | Approved | None posted |
| Jun 28, 1995 | Supplement 21Labeling | Approved | None posted |
| Aug 2, 1994 | Supplement 20Labeling | Approved | None posted |
| Oct 24, 1989 | Supplement 18Labeling | Approved | None posted |
| Feb 22, 1989 | Supplement 17Manufacturing | Approved | None posted |
| Aug 10, 1988 | Supplement 16Manufacturing | Approved | None posted |
| Jun 24, 1987 | Supplement 12Manufacturing | Approved | None posted |
| Jun 24, 1987 | Supplement 13Manufacturing | Approved | None posted |
| May 18, 1987 | Supplement 9Manufacturing | Approved | None posted |
| May 18, 1987 | Supplement 10Manufacturing | Approved | None posted |
| Sep 23, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Jul 24, 1986 | Supplement 7Manufacturing | Approved | None posted |
| Nov 23, 1984 | Supplement 1Manufacturing | Approved | None posted |
| Nov 23, 1984 | Supplement 2Manufacturing | Approved | None posted |
| Nov 23, 1984 | Supplement 3Manufacturing | Approved | None posted |
| Sep 18, 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
