ANDA 202524, held by Rouses Point Pharms. Levetiracetam.
As of Nov 15, 2026, ANDA 202524 (Levetiracetam), held by Rouses Point Pharms, was first approved by FDA on Aug 27, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2012 | Original application | Approved | None posted |
| Levetiracetam500MG · tablet, extended release;oral | Levetiracetam | Discontinued |
| Levetiracetam750MG · tablet, extended release;oral | Levetiracetam | Discontinued |
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
