Data updated: Mar 10, 2026
ALLOPURINOL
ALLOPURINOL
Approved 1984-09-28
19
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-09-28
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
IPCA LABS LTD ACCORD HLTHCARE PURACAP PHARM PUREPAC PHARM SUPERPHARM CHARTWELL REGCON HOLDINGS Viatris MUTUAL PHARM NORTHSTAR HLTHCARE WATSON LABS Novartis Sun Pharma AIPING PHARM INC HARMAN FINOCHEM Aurobindo Pharma ZYDUS PHARMS UNICHEM Lupin HETERO LABS LTD V PH HEALTH
Active Ingredient: ALLOPURINOL
Website: ↗
ALLOPURINOL Approval History
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What ALLOPURINOL Treats
19 FDA approvalsOriginally approved for its first indication in 1984 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (Sep 1984)
- • Approved indication (Dec 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Oct 1986)
- • Approved indication (Jan 1987)
- • Approved indication (Jun 2003)
- • Approved indication (Sep 2005)
- • Approved indication (Aug 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Mar 2011)
- • Approved indication (May 2013)
- • Approved indication (Jul 2016)
- • Approved indication (Oct 2017)
- • Approved indication (Mar 2019)
- • Approved indication (Mar 2022)
- • Approved indication (Aug 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Apr 2025) New
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
ALLOPURINOL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.