ANDA 77399, held by Hikma. Levocarnitine.
As of Nov 13, 2026, ANDA 77399 (Levocarnitine), held by Hikma, was first approved by FDA on Oct 25, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 25, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine1GM/10ML ยท solution;oral | Levocarnitine | 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
