ANDA 209934, held by Epic Pharma LLC. Levetiracetam.
As of Nov 15, 2026, ANDA 209934 (Levetiracetam), held by Epic Pharma LLC, was first approved by FDA on May 4, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous | Levetiracetam | Discontinued |
| Aug 15, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 15, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 4, 2018 | 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
