Controls absence (petit mal) epilepsy. ANDA 80258, held by Parke-Davis. Ethosuximide.
As of Nov 13, 2026, ANDA 80258 (Zarontin), held by Parke-Davis, was first approved by FDA on Feb 13, 1974, with 14 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ethosuximide is indicated for the control of absence (petit mal) epilepsy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zarontin250MG/5ML · syrup;oral | Ethosuximide | RxReference drug |
| Oct 29, 2021 | Supplement 35Labeling · Standard review | Approved | None posted |
| Oct 29, 2021 | Supplement 32Labeling · Standard review | Approved | None posted |
| Jan 16, 2014 | Supplement 31Labeling · Standard review | Approved | |
| Jan 16, 2014 | Supplement 29Labeling · Standard review | Approved | |
| Oct 25, 2012 | Supplement 30REMS | Approved | None posted |
| Apr 25, 2011 | Supplement 28REMS | Approved | None posted |
| Nov 20, 2009 | Supplement 27Labeling | Approved | None posted |
| Nov 20, 2009 | Supplement 26Labeling | Approved | None posted |
| May 6, 2009 | Supplement 25Labeling | Approved | |
| Oct 3, 2006 | Supplement 20Labeling | Approved | None posted |
| Oct 27, 1998 | Supplement 16Manufacturing | Approved | None posted |
| Oct 22, 1997 | Supplement 14Manufacturing | Approved | None posted |
| Mar 13, 1996 | Supplement 13Manufacturing | Approved | None posted |
| Jul 28, 1995 | Supplement 12Manufacturing | Approved | None posted |
| Feb 13, 1974 | 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
