Allopurinol

Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 71450, held by Sun Pharm Industries. Allopurinol.

As of Nov 15, 2026, ANDA 71450 (Allopurinol), held by Sun Pharm Industries, was first approved by FDA on Jan 9, 1987, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 9, 1987
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS ). Allopurinol is indicated in: 1. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 9, 1987	Original application	Approved	None posted

Products

2 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Jan 29, 2024	Supplement 44Labeling · Standard review	Approved	None posted
May 15, 2019	Supplement 40Labeling · Standard review	Approved	None posted
Aug 22, 2007	Supplement 31Labeling	Approved	None posted
Apr 27, 2001	Supplement 14Manufacturing	Approved	None posted
May 16, 2000	Supplement 12Manufacturing	Approved	None posted
May 16, 2000	Supplement 13Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 11Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 10Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 9Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 8Manufacturing	Approved	None posted
Feb 4, 1991	Supplement 6Labeling	Approved	None posted
Feb 4, 1991	Supplement 45Labeling	Approved	None posted
Jul 9, 1990	Supplement 3Manufacturing	Approved	None posted
Sep 1, 1987	Supplement 2Manufacturing	Approved	None posted
Jan 9, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71450
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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