Controls absence (petit mal) epilepsy. ANDA 210654, held by Puracap Pharm LLC. Ethosuximide.
As of Nov 13, 2026, ANDA 210654 (Ethosuximide), held by Puracap Pharm LLC, was first approved by FDA on Mar 16, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Ethosuximide is indicated for the control of absence (petit mal) epilepsy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethosuximide250MG · capsule;oral | Ethosuximide | Rx |
| Aug 16, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 16, 2020 | 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
