Regulatory PathRegulatory requirements compared

Active substance

Leucovorin

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LEUCOVORIN CALCIUMEQ 50MG BASE/VIALinjectable · injectionHIKMA PHARMSPrescription14 Sep 1987
LEUCOVORIN CALCIUMEQ 5MG BASEtablet · oralBARRPrescription24 Sep 1987
LEUCOVORIN CALCIUMEQ 25MG BASEtablet · oralBARRPrescription24 Sep 1987
LEUCOVORIN CALCIUMEQ 100MG BASE/VIALinjectable · injectionHIKMA PHARMSPrescription28 Mar 1988
LEUCOVORIN CALCIUMEQ 5MG BASEtablet · oralHIKMA PHARMSPrescription22 Feb 1993
LEUCOVORIN CALCIUMEQ 10MG BASEtablet · oralHIKMA PHARMSPrescription22 Feb 1993
LEUCOVORIN CALCIUMEQ 15MG BASEtablet · oralHIKMA PHARMSPrescription22 Feb 1993
LEUCOVORIN CALCIUMEQ 25MG BASEtablet · oralHIKMA PHARMSPrescription22 Feb 1993
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALinjectable · injectionHIKMA PHARMSPrescription23 May 1995
LEUCOVORIN CALCIUMEQ 5MG BASE; EQ 25MG BASE; EQ 10MG BASE; EQ 15MG BASEtablet · oralEPIC PHARMA LLCPrescription28 Aug 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 200MG BASE/VIALinjectable · injectionFRESENIUS KABI USAPrescription26 Feb 1999
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 500MG BASE/VIALinjectable · injectionFRESENIUS KABI USAPrescription26 Feb 1999
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALinjectable · injectionHIKMA PHARMSPrescription20 Apr 2000
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL; EQ 200MG BASE/VIALinjectable · injectionSAGENT PHARMSPrescription6 Sep 2012
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 350MG BASE/VIALinjectable · injectionSAGENT PHARMSPrescription6 Sep 2012
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 100MG BASE/VIAL; EQ 200MG BASE/VIAL; EQ 350MG BASE/VIALinjectable · injectionMYLAN LABS LTDPrescription19 May 2017
LEUCOVORIN CALCIUM PRESERVATIVE FREEEQ 500MG BASE/VIALinjectable · injectionSAGENT PHARMS INCPrescription26 Oct 2017
LEUCOVORIN CALCIUMEQ 100MG BASE/10ML (EQ 10MG BASE/ML)solution · intramuscular, intravenousFRESENIUS KABI USAPrescription14 Mar 2018
LEUCOVORIN CALCIUMEQ 500MG BASE/50ML (EQ 10MG BASE/ML)solution · intramuscular, intravenousFRESENIUS KABI USAPrescription27 Jul 2018
LEUCOVORIN CALCIUMEQ 5MG BASE; EQ 10MG BASE; EQ 15MG BASE; EQ 25MG BASEtablet · oralINGENUS PHARMS LLCPrescription30 Jul 2020
LEUCOVORIN CALCIUMEQ 5MG BASE; EQ 10MG BASE; EQ 15MG BASE; EQ 25MG BASEtablet · oralLEADINGPrescription22 Oct 2020
LEUCOVORIN CALCIUMEQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL; EQ 200MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 350MG BASE/VIALinjectable · injectionHAINAN POLYPrescription10 Jul 2023
LEUCOVORIN CALCIUMEQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL; EQ 200MG BASE/VIAL; EQ 350MG BASE/VIAL; EQ 500MG BASE/VIALinjectable · injectionMEITHEALPrescription19 Jul 2023
LEUCOVORIN CALCIUMEQ 350MG BASE/VIALinjectable · injectionGLANDPrescription12 Nov 2025
VYKOURAEQ 50MG BASE/5ML (EQ 10MG BASE/ML); EQ 350MG BASE/35ML (EQ 10MG BASE/ML); EQ 500MG BASE/50ML (EQ 10MG BASE/ML)solution · intramuscular, intravenousAVYXA HOLDINGSPrescription3 Feb 2026

36 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP LEUCOVORIN025482085 MGTABLET · ORALJAMP PHARMA CORPORATION
LEDERLE LEUCOVORIN021704935 MGTABLET · ORALPFIZER CANADA ULC
LEUCOVORIN CALCIUM INJECTION0208731610 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARTEVA CANADA LIMITED
LEUCOVORIN CALCIUM INJECTION0248004210 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSGENERIC MEDICAL PARTNERS INC
LEUCOVORIN CALCIUM INJECTION024969251000 MG / 100 MLSOLUTION · INTRAVENOUSGENERIC MEDICAL PARTNERS INC
LEUCOVORIN CALCIUM INJECTION USP0218299810 MG / MLSOLUTION · INTRAVENOUSPFIZER CANADA ULC
LEUCOVORIN CALCIUM INJECTION USP0218300510 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSPFIZER CANADA ULC
MINT-LEUCOVORIN024968285 MGTABLET · ORALMINT PHARMACEUTICALS INC
RIVA LEUCOVORIN024933575 MGTABLET · ORALLABORATOIRE RIVA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLEUCOVORIN CALCIUM 10 MG TAB$2.07783per EA23 Sep 2026
US NADACLEUCOVORIN CALCIUM 15 MG TAB$1.58667per EA23 Sep 2026
US NADACLEUCOVORIN CALCIUM 25 MG TAB$1.60475per EA23 Sep 2026
US NADACLEUCOVORIN CALCIUM 5 MG TAB$0.33003per EA23 Sep 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.

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.