FDA — authorised 27 December 1985
- Application: NDA018948
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Local brand name: CARNITOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 L-carnitine in United States
FDA authorised L-carnitine on 27 December 1985 · 715 US adverse-event reports
Marketing authorisations
FDA — authorised 29 March 2001
- Application: ANDA075881
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LEVOCARNITINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2001
- Application: ANDA075567
- Marketing authorisation holder: HIKMA
- Local brand name: LEVOCARNITINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 June 2001
- Application: ANDA075861
- Marketing authorisation holder: AM REGENT
- Local brand name: LEVOCARNITINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 August 2004
- Application: ANDA076851
- Marketing authorisation holder: RISING
- Local brand name: LEVOCARNITINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 September 2004
- Application: ANDA076858
- Marketing authorisation holder: RISING
- Local brand name: LEVOCARNITINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2007
- Application: ANDA077399
- Marketing authorisation holder: HIKMA
- Local brand name: LEVOCARNITINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 14 August 2019
- Application: ANDA211676
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: LEVOCARNITINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 November 2021
- Application: ANDA212533
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: LEVOCARNITINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 June 2025
- Application: ANDA217430
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: LEVOCARNITINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 715
Most-reported reactions
- Fatigue — 111 reports (15.52%)
- Nausea — 84 reports (11.75%)
- Diarrhoea — 77 reports (10.77%)
- Headache — 77 reports (10.77%)
- Drug Ineffective — 73 reports (10.21%)
- Dizziness — 64 reports (8.95%)
- Pain — 60 reports (8.39%)
- Dyspnoea — 57 reports (7.97%)
- Asthenia — 56 reports (7.83%)
- Insomnia — 56 reports (7.83%)
L-carnitine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is L-carnitine approved in United States?
Yes. FDA authorised it on 27 December 1985; FDA authorised it on 29 March 2001; FDA authorised it on 29 March 2001.
Who is the marketing authorisation holder for L-carnitine in United States?
LEADIANT BIOSCI INC holds the US marketing authorisation.