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Data updated: May 26, 2026

CALCIUM DISODIUM VERSENATE (edetate calcium disodium)

Other Approved 1953-07-16
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
72
Years on Market

Details

Status
Discontinued
First Approved
1953-07-16
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, TABLET

Companies

BAUSCH
Active Ingredient: EDETATE CALCIUM DISODIUM

CALCIUM DISODIUM VERSENATE Approval History

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Original
New Indication
New Form
Label Update
20 FDA actions from 1953 to 2023
Sep 2023 SUPPL
Label · Labeling
FDA Letter Label
Jun 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Jun 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
FDA Letter Label

What CALCIUM DISODIUM VERSENATE Treats

1 FDA approvals

Originally approved for its first indication in 1953 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03630991 2017-0752 NCI-2018-01610, 2017-0752 Ph 1 recruiting Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
NCT02421029 MRI-EDTA Ph 4 withdrawn Prolonged Gadolinium Retention After MRI Imaging
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CALCIUM DISODIUM VERSENATE FDA Label Details

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Data Sources

FDA Approval: NDA008922 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.