Treats an inborn error of metabolism. ANDA 75861, held by Am Regent. Levocarnitine.
As of Nov 13, 2026, ANDA 75861 (Levocarnitine), held by Am Regent, was first approved by FDA on Jun 22, 2001, with 2 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 |
|---|---|---|---|
| Jun 22, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine200MG/ML · injectable;injection | Levocarnitine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 25, 2023 | Supplement 12Manufacturing | Approved | None posted |
| Dec 15, 2022 | Supplement 11Manufacturing | Approved | None posted |
| Jun 22, 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
