Regulatory PathRegulatory requirements compared

Active substance

Levocarnitine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
CARNITOR330MGtablet · oralLEADIANT BIOSCI INCPrescription27 Dec 1985
CARNITOR1GM/10MLsolution · oralLEADIANT BIOSCI INCPrescription10 Apr 1986
CARNITOR SF1GM/10MLsolution · oralLEADIANT BIOSCI INCPrescription10 Apr 1986
CARNITOR200MG/MLinjectable · injectionLEADIANT BIOSCI INCPrescription16 Dec 1992
LEVOCARNITINE200MG/MLinjectable · injectionHIKMA PHARMSPrescription29 Mar 2001
LEVOCARNITINE200MG/MLinjectable · injectionAM REGENTPrescription22 Jun 2001
LEVOCARNITINE1GM/10MLsolution · oralRISINGPrescription10 Aug 2004
LEVOCARNITINE330MGtablet · oralRISINGPrescription20 Sep 2004
LEVOCARNITINE1GM/10MLsolution · oralNOVITIUM PHARMAPrescription14 Aug 2019
LEVOCARNITINE SF1GM/10MLsolution · oralNOVITIUM PHARMAPrescription14 Aug 2019
LEVOCARNITINE1GM/10MLsolution · oralSCIEGEN PHARMSPrescription10 Nov 2021
LEVOCARNITINE330MGtablet · oralNOVITIUM PHARMAPrescription9 Dec 2022
LEVOCARNITINE200MG/MLinjectable · injectionDEVA HOLDING ASPrescription30 Jun 2025
LEVOCARNITINE200MG/MLinjectable · injectionBAXTER HLTHCARE CORPPrescription2 Jul 2026
LEVOCARNITINE200MG/MLinjectable · injectionGLANDPrescription30 Sep 2026
CARNITOR1GM/10MLsolution · oralLEADIANT BIOSCI INCDiscontinued27 Dec 1985
LEVOCARNITINE200MG/MLinjectable · injectionTEVA PHARMS USADiscontinued29 Mar 2001
LEVOCARNITINE1GM/10MLsolution · oralHIKMA PHARMSDiscontinued25 Oct 2007

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CARNITOR02144328330 MGTABLET · ORALLEADIANT BIOSCIENCES, INC
CARNITOR02144336100 MG / MLSOLUTION · ORALLEADIANT BIOSCIENCES, INC
CARNITOR02144344200 MG / MLSOLUTION · INTRAVENOUSLEADIANT BIOSCIENCES, INC
ODAN LEVOCARNITINE02492105100 MG / MLSOLUTION · ORALODAN LABORATORIESLTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLEVOCARNITINE 1 G/10 ML SOLN$0.14503per ML23 Sep 2026
US NADACLEVOCARNITINE 330 MG TABLET$0.67062per EA23 Sep 2026
US NADACLEVOCARNITINE SF 1 G/10 ML SOL$0.25217per ML23 Sep 2026
NHS Drug TariffLevocarnitine 1.5g/5ml oral solution paediatric sugar free£71.4020 ml1 Oct 2026
NHS Drug TariffLevocarnitine 1.5g/5ml oral solution paediatric sugar free£178.5050 ml1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for levocarnitine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.