ANDA 87266, held by Olta Pharms. Lindane.
As of Nov 13, 2026, ANDA 87266 (Lindane), held by Olta Pharms, was first approved by FDA on Dec 17, 1981, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 1981 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lindane1% ยท shampoo;topical | Lindane | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2004 | Supplement 23Labeling | Approved | None posted |
| Oct 9, 2001 | Supplement 21Manufacturing | Approved | None posted |
| Dec 29, 2000 | Supplement 20Manufacturing | Approved | None posted |
| Dec 29, 2000 | Supplement 19Manufacturing | Approved | None posted |
| May 17, 1996 | Supplement 17Labeling | Approved | None posted |
| Aug 2, 1994 | Supplement 16Labeling | Approved | None posted |
| Jun 4, 1992 | Supplement 13Labeling | Approved | None posted |
| Apr 15, 1991 | Supplement 15Manufacturing | Approved | None posted |
| Sep 28, 1990 | Supplement 14Manufacturing | Approved | None posted |
| Feb 3, 1989 | Supplement 12Manufacturing | Approved | None posted |
| Jan 26, 1989 | Supplement 11Manufacturing | Approved | None posted |
| Jul 7, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Dec 17, 1981 | Original application | Approved |
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
