TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DIABETA

GLYBURIDE
Metabolic Approved 1984-05-01
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1984-05-01
Routes
ORAL
Dosage Forms
TABLET

Companies

Sanofi
Active Ingredient: GLYBURIDE

DIABETA Approval History

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What DIABETA Treats

1 indications

DIABETA is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Type 2 Diabetes
Source: FDA Label

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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.

DIABETA FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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Data Sources

FDA Approval: NDA017532 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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