TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

SUCRALFATE

SUCRALFATE
Approved 1996-03-29
Jump to: Indications Approvals Trials Competitors Safety Patents
14
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Discontinued
First Approved
1996-03-29
Routes
ORAL
Dosage Forms
SUSPENSION, TABLET

Companies

Hikma Teva ABON PHARMS LLC VISTAPHARM LLC GLENMARK PHARMS LTD Viatris COSETTE STRIDES PHARMA CHARTWELL RX ZYDUS LIFESCIENCES AMNEAL PADAGIS US AMNEAL PHARMS PD PARTNERS
Active Ingredient: SUCRALFATE

SUCRALFATE Approval History

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What SUCRALFATE Treats

14 FDA approvals

Originally approved for its first indication in 1996 . Covers 14 distinct patient populations.

  • Other (14)
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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.

SUCRALFATE FDA Label Details

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Data Sources

FDA Approval: ANDA212769 → Trials: ClinicalTrials.gov →

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