Treats an inborn error of metabolism. ANDA 220181, held by Gland. Levocarnitine.
As of Nov 13, 2026, ANDA 220181 (Levocarnitine), held by Gland, was first approved by FDA on Sep 30, 2026, with 0 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 |
|---|---|---|---|
| Sep 30, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine200MG/ML · injectable;injection | Levocarnitine | 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
