Treats primary systemic carnitine deficiency. Sold as Carnitor, Carnitor Sf. Every FDA application for this active ingredient: 3 branded and 12 generic.
As of Nov 13, 2026, FDA lists 15 applications for Levocarnitine (sold as Carnitor, Carnitor Sf), first approved Dec 27, 1985, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Carnitor | Part B | $2.6M | -23% | 1,502 |
| Levocarnitine SF | Part D | $91K | +16% | 179 |
| Carnitor SF | Part D | $6K | -32% | 0 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 27, 1985 | CarnitorNDA 18948 · New molecular entity | Leadiant Biosci Inc | 22 | Marketed |
| Apr 10, 1986 | Carnitor, Carnitor SfNDA 19257 · New dosage form | Leadiant Biosci Inc | 12 | Marketed |
| Dec 16, 1992 | CarnitorNDA 20182 · New dosage form | Leadiant Biosci Inc | 10 | Marketed |
| Mar 29, 2001 | LevocarnitineANDA 75567 | Hikma | 4 | Marketed |
| Mar 29, 2001 | LevocarnitineANDA 75881 | Teva Pharms USA | 2 | Discontinued |
| Jun 22, 2001 | LevocarnitineANDA 75861 | Am Regent | 2 | Marketed |
| Aug 10, 2004 | LevocarnitineANDA 76851 | Rising | 0 | Marketed |
| Sep 20, 2004 | LevocarnitineANDA 76858 | Rising | 1 | Marketed |
| Oct 25, 2007 | LevocarnitineANDA 77399 | Hikma | 0 | Discontinued |
| Aug 14, 2019 | Levocarnitine, Levocarnitine SfANDA 211676 | Novitium Pharma | 0 | Marketed |
| Nov 10, 2021 | LevocarnitineANDA 212533 | Sciegen Pharms | 1 | Marketed |
| Dec 9, 2022 | LevocarnitineANDA 216384 | Novitium Pharma | 0 | Marketed |
| Jun 30, 2025 | LevocarnitineANDA 217430 | Deva Holding As | 0 | Marketed |
| Jul 2, 2026 | LevocarnitineANDA 217896 | Baxter Hlthcare Corp | 0 | Marketed |
| Sep 30, 2026 | LevocarnitineANDA 220181 | Gland | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
