ANDA 218364, held by Mylan Labs Ltd. Levetiracetam.
As of Nov 15, 2026, ANDA 218364 (Levetiracetam In Sodium Chloride), held by Mylan Labs Ltd, was first approved by FDA on May 8, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2026 | Original application | Approved | None posted |
| Levetiracetam In Sodium Chloride500MG/100ML (5MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Levetiracetam In Sodium Chloride1GM/100ML (10MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Levetiracetam In Sodium Chloride1.5GM/100ML (15MG/ML) · injectable;intravenous | 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
