ANDA 81306, held by Teva Pharms. Ethosuximide.
As of Nov 13, 2026, ANDA 81306 (Ethosuximide), held by Teva Pharms, was first approved by FDA on Jul 30, 1993, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethosuximide250MG/5ML ยท syrup;oral | Ethosuximide | Discontinued |
| Jun 29, 2010 | Supplement 17Labeling | Approved | None posted |
| Sep 27, 2002 | Supplement 14Labeling | Approved | None posted |
| Apr 8, 2002 | Supplement 13Labeling | Approved | None posted |
| Jan 23, 2002 | Supplement 7Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Feb 26, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Sep 20, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Oct 29, 1998 | Supplement 3Manufacturing | Approved | None posted |
| May 31, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Jan 21, 1994 | Supplement 1Manufacturing | Approved | None posted |
| Jul 30, 1993 | 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
