TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FLUCONAZOLE

FLUCONAZOLE
Approved 2004-07-29
Jump to: Indications Approvals Trials Competitors Safety Patents
12
Indications
--
Phase 3 Trials
21
Years on Market

Details

Status
Discontinued
First Approved
2004-07-29
Routes
ORAL
Dosage Forms
FOR SUSPENSION, TABLET

Companies

Sun Pharma CHARTWELL ZHEJIANG POLY PHARM Teva GLENMARK PHARMS LTD Hikma Lupin FDC LTD RANBAXY LABS LTD TARO PHARM INDS Aurobindo Pharma ZYDUS PHARMS IVAX SUB TEVA PHARMS ROXANE THINQ PHARM-CRO PVT PLIVA GEDEON RICHTER USA Dr. Reddy's ANI PHARMS PHARMOBEDIENT TARO Viatris
Active Ingredient: FLUCONAZOLE

FLUCONAZOLE Approval History

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What FLUCONAZOLE Treats

12 FDA approvals

Originally approved for its first indication in 2004 . Covers 12 distinct patient populations.

  • Other (12)
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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.

FLUCONAZOLE FDA Label Details

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Data Sources

FDA Approval: ANDA076332 → Trials: ClinicalTrials.gov →

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