Treats primary systemic carnitine deficiency. ANDA 212533, held by Sciegen Pharms. Levocarnitine.
As of Nov 13, 2026, ANDA 212533 (Levocarnitine), held by Sciegen Pharms, was first approved by FDA on Nov 10, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 10, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine1GM/10ML · solution;oral | Levocarnitine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 5, 2023 | Supplement 3Manufacturing | Approved | None posted |
| Nov 10, 2021 | Original application | Approved | None posted |
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
