Active substance
Levoleucovorin
- US FDA 19
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | solution · intravenous | SANDOZ | Prescription | 9 Mar 2015 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML); EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | solution · intravenous | GLAND | Prescription | 14 Sep 2018 |
| KHAPZORY | 175MG/VIAL | powder · intravenous | ACROTECH BIOPHARMA | Prescription | 19 Oct 2018 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | solution · intravenous | MEITHEAL | Prescription | 16 Aug 2019 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML); EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | solution · intravenous | HAINAN POLY PHARM | Prescription | 22 May 2023 |
| FUSILEV | EQ 50MG BASE/VIAL | powder · intravenous | ACROTECH BIOPHARMA | Discontinued | 7 Mar 2008 |
| FUSILEV | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intravenous | ACROTECH BIOPHARMA | Discontinued | 7 Mar 2008 |
| LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | solution · intravenous | SANDOZ | Discontinued | 9 Mar 2015 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML); EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | solution · intravenous | PHARMOBEDIENT | Discontinued | 20 Oct 2015 |
| LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | powder · intravenous | HIKMA PHARMS | Discontinued | 16 Jun 2016 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/VIAL | powder · intravenous | ACTAVIS LLC | Discontinued | 29 Sep 2016 |
| LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | powder · intravenous | ACTAVIS LLC | Discontinued | 13 Feb 2017 |
| LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | powder · intravenous | AMNEAL | Discontinued | 13 Feb 2017 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | solution · intravenous | AMNEAL | Discontinued | 8 Sep 2017 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML); EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | solution · intravenous | INGENUS PHARMS LLC | Discontinued | 3 May 2018 |
| KHAPZORY | 300MG/VIAL | powder · intravenous | ACROTECH BIOPHARMA | Discontinued | 19 Oct 2018 |
| LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | solution · intravenous | MEITHEAL | Discontinued | 16 Aug 2019 |
| LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | powder · intravenous | MEITHEAL | Discontinued | 22 Aug 2019 |
| LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | solution · intravenous | QUAGEN | Discontinued | 2 Nov 2021 |
Safety signals and safety-related labeling changes
- US FDA 3 Mar 2020 KHAPZORY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions - US FDA 8 Jan 2020 FUSILEV — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
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.