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Data updated: Mar 10, 2026

GLYBURIDE

GLYBURIDE
Metabolic Approved 1995-08-29
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
10
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-08-29
Routes
ORAL
Dosage Forms
TABLET

Companies

IMPAX LABS INC Teva EPIC PHARMA LLC CHARTWELL RX Aurobindo Pharma HERITAGE CADILA PHARMS LTD ZYDUS PHARMS ORIENT PHARMA CO LTD
Active Ingredient: GLYBURIDE

GLYBURIDE Approval History

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What GLYBURIDE Treats

1 indications

GLYBURIDE is approved for 1 conditions since its original approval in 1995. 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.

GLYBURIDE FDA Label Details

Pro

Indications & Usage

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: ANDA206079 → Label: DailyMed → Trials: ClinicalTrials.gov →

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