Allopurinol

Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 210117, held by Zydus Pharms. Allopurinol.

As of Nov 15, 2026, ANDA 210117 (Allopurinol), held by Zydus Pharms, was first approved by FDA on Oct 12, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 12, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Allopurinol tablet is 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 (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars a…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 12, 2017	Original application	Approved	None posted

Products

3 strengths and forms


Allopurinol100MG · tablet;oral	Allopurinol	Rx
Allopurinol300MG · tablet;oral	Allopurinol	Rx
Allopurinol200MG · tablet;oral	Allopurinol	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 13, 2025	Supplement 6Manufacturing	Approved	None posted
Feb 5, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Oct 12, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 210117
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters