ANDA 78731, held by Mylan. Levetiracetam.
As of Nov 15, 2026, ANDA 78731 (Levetiracetam), held by Mylan, was first approved by FDA on Feb 10, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2009 | Original application | Approved | None posted |
| Levetiracetam250MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam500MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam750MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam1GM · tablet;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
