TheraRadar
Data updated: Mar 29, 2026

AZELAIC ACID

AZELAIC ACID
Approved 2018-11-19
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2018-11-19
Routes
TOPICAL
Dosage Forms
AEROSOL, FOAM, GEL

Companies

TARO PHARM INDS LTD ENCUBE GLENMARK SPECLT Teva SUN PHARMA CANADA Aurobindo Pharma
Active Ingredient: AZELAIC ACID

AZELAIC ACID Approval History

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What AZELAIC ACID Treats

3 FDA approvals

Originally approved for its first indication in 2018 . Covers 3 distinct patient populations.

  • Other (3)
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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.

AZELAIC ACID FDA Label Details

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Data Sources

FDA Approval: ANDA212581 → Trials: ClinicalTrials.gov →

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