TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ACCOLATE

ZAFIRLUKAST Leukotriene Receptor Antagonists
Respiratory Approved 1996-09-26
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1996-09-26
Routes
ORAL
Dosage Forms
TABLET

Companies

STRIDES PHARMA INTL
Active Ingredient: ZAFIRLUKAST

ACCOLATE Approval History

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What ACCOLATE Treats

1 indications

ACCOLATE is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
Source: FDA Label

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Key Completed Trials

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Trial Timeline

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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.

ACCOLATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

ACCOLATE is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

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Data Sources

FDA Approval: NDA020547 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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