Data updated: Mar 10, 2026
LEUCOVORIN CALCIUM PRESERVATIVE FREE
LEUCOVORIN CALCIUM
Approved 1995-05-23
10
Indications
--
Phase 3 Trials
30
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1995-05-23
- Routes
- INTRAMUSCULAR, INTRAVENOUS, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE
LEUCOVORIN CALCIUM PRESERVATIVE FREE Approval History
Loading approval history...
What LEUCOVORIN CALCIUM PRESERVATIVE FREE Treats
10 FDA approvalsOriginally approved for its first indication in 1995 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (May 1995)
- • Approved indication (Jun 1997)
- • Approved indication (Feb 1999)Letter
- • Approved indication (Jun 1999)Letter
- • Approved indication (Apr 2000)Letter
- • Approved indication (Apr 2000)Label Letter
- • Approved indication (Jan 2001)Letter
- • Approved indication (Sep 2012)
- • Approved indication (May 2017)
- • Approved indication (Oct 2017)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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 PRESERVATIVE FREE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.