Treats primary systemic carnitine deficiency. ANDA 76858, held by Rising. Levocarnitine.
As of Nov 13, 2026, ANDA 76858 (Levocarnitine), held by Rising, was first approved by FDA on Sep 20, 2004, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Levocarnitine tablets are 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 |
|---|---|---|---|
| Sep 20, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine330MG · tablet;oral | Levocarnitine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 20, 2004 | 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
