Treats an inborn error of metabolism. ANDA 75567, held by Hikma. Levocarnitine.
As of Nov 13, 2026, ANDA 75567 (Levocarnitine), held by Hikma, was first approved by FDA on Mar 29, 2001, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine200MG/ML · injectable;injection | Levocarnitine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 16, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 4, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Jul 23, 2001 | 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
