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Data updated: Mar 10, 2026

ZYLOPRIM

ALLOPURINOL Xanthine Oxidase Inhibitors
Oncology Approved 1966-08-19
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
59
Years on Market

Details

Status
Prescription
First Approved
1966-08-19
Routes
ORAL
Dosage Forms
TABLET

Companies

CASPER PHARMA LLC
Active Ingredient: ALLOPURINOL

ZYLOPRIM Approval History

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What ZYLOPRIM Treats

5 indications

ZYLOPRIM is approved for 5 conditions since its original approval in 1966. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gout
  • Leukemia
  • Lymphoma
  • Solid Tumor Malignancies
  • Calcium Oxalate Calculi
Source: FDA Label

ZYLOPRIM Boxed Warning

BOXED WARNING...

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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.

ZYLOPRIM FDA Label Details

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Indications & Usage

FDA Label (PDF)

Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (suc...

⚠️ BOXED WARNING

BOXED WARNING...

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Data Sources

FDA Approval: NDA016084 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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