ANDA 75881, held by Teva Pharms USA. Levocarnitine.
As of Nov 13, 2026, ANDA 75881 (Levocarnitine), held by Teva Pharms USA, was first approved by FDA on Mar 29, 2001, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine200MG/ML ยท injectable;injection | Levocarnitine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2012 | Supplement 13Labeling | Approved | None posted |
| Apr 11, 2002 | Supplement 1Labeling | Approved | None posted |
| Mar 29, 2001 | Original application | Approved |
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
