ANDA 215465, held by Knack. Levetiracetam.
As of Nov 15, 2026, ANDA 215465 (Levetiracetam), held by Knack, was first approved by FDA on Dec 2, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 2, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam500MG/5ML (100MG/ML) ยท injectable;intravenous | 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
