Data updated: Mar 10, 2026
LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM
Approved 1952-06-20
28
Indications
--
Phase 3 Trials
1
Priority Reviews
73
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1952-06-20
- Routes
- INJECTION, ORAL, Injection, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE, TABLET, Injectable, SOLUTION, FOR SOLUTION
Companies
Teva Hikma PHARMACHEMIE QUAD PHARMS NOVAST LABS MEITHEAL ELKINS SINN PAR PHARM ABIC ABRAXIS PHARM PHARMACHEMIE USA ANI PHARMS HAINAN POLY GLAND Fresenius Kabi XANODYNE PHARM EPIC PHARMA LLC Pfizer LEADING
Active Ingredient: LEUCOVORIN CALCIUM
Website: ↗
LEUCOVORIN CALCIUM Approval History
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What LEUCOVORIN CALCIUM Treats
28 FDA approvalsOriginally approved for its first indication in 1952 . Covers 28 distinct patient populations.
- Other (28)
Other
(28 approvals)- • Approved indication (Jun 1952) Priority
- • Approved indication (Feb 1980)
- • Approved indication (Jan 1987)
- • Approved indication (Jan 1987)
- • Approved indication (Mar 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Nov 1987)
- • Approved indication (Mar 1988)
- • Approved indication (Aug 1988)
- • Approved indication (Dec 1991)
- • Approved indication (Feb 1993)
- • Approved indication (Sep 1993)
- • Approved indication (Jun 1994)
- • Approved indication (Mar 1997)
- • Approved indication (Apr 1997)
- • Approved indication (Jun 1997)
- • Approved indication (Aug 1997)
- • Approved indication (Mar 1999)Letter
- • Approved indication (Dec 1999)Label Letter
- • Approved indication (Mar 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Jul 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Jul 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Nov 2025) New
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEUCOVORIN CALCIUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.