ANDA 203067, held by Alembic. Levetiracetam.
As of Nov 15, 2026, ANDA 203067 (Levetiracetam), held by Alembic, was first approved by FDA on May 9, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam100MG/ML ยท solution;oral | Levetiracetam | Rx |
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
