Allopurinol

Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. NDA 18877, held by Watson Labs. Allopurinol.

As of Nov 13, 2026, NDA 18877 (Allopurinol), held by Watson Labs, was first approved by FDA on Sep 28, 1984, with 26 approved supplements and 0 published complete response letters.

First approved: Sep 28, 1984
Supplements approved: 26
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: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Sep 28, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Allopurinol300MG · tablet;oral	Allopurinol	Rx

All 27 submissions, including labeling and manufacturing supplements


Apr 3, 2024	Supplement 68Labeling · Standard review	Approved	Letter Label
Apr 3, 2024	Supplement 65Labeling · Standard review	Approved	Letter Label
Apr 3, 2024	Supplement 63Labeling · Standard review	Approved	Letter Label
Nov 13, 2015	Supplement 62Manufacturing	Approved	None posted
Jan 23, 2009	Supplement 45Labeling	Approved	None posted
Aug 26, 2003	Supplement 28Labeling	Approved	None posted
Aug 14, 2002	Supplement 31Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 30Manufacturing	Approved	None posted
Feb 5, 2001	Supplement 29Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 26Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 25Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 21Manufacturing	Approved	None posted
May 31, 1991	Supplement 19Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 20Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 18Manufacturing	Approved	None posted
Jul 7, 1988	Supplement 17Manufacturing	Approved	None posted
Jul 7, 1988	Supplement 16Manufacturing	Approved	None posted
Dec 17, 1987	Supplement 15Manufacturing	Approved	None posted
Dec 17, 1987	Supplement 14Manufacturing	Approved	None posted
Dec 17, 1987	Supplement 13Manufacturing	Approved	None posted
Mar 11, 1987	Supplement 11Manufacturing	Approved	None posted
Jul 3, 1985	Supplement 7Manufacturing	Approved	None posted
Jul 3, 1985	Supplement 6Manufacturing	Approved	None posted
Jul 3, 1985	Supplement 2Manufacturing	Approved	None posted
May 10, 1985	Supplement 4Manufacturing	Approved	None posted
May 10, 1985	Supplement 3Manufacturing	Approved	None posted
Sep 28, 1984	Original application	Approved	None posted

Identifiers

Application: NDA 18877
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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