Allopurinol

Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 18659, held by Mylan. Allopurinol.

As of Nov 15, 2026, ANDA 18659 (Allopurinol), held by Mylan, was first approved by FDA on Oct 24, 1986, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1986
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and i…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Oct 24, 1986	Original application	Approved	None posted

Products

2 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


Mar 12, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Sep 18, 2023	Supplement 30Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Jul 31, 2003	Supplement 14Labeling	Approved	None posted
Nov 13, 2002	Supplement 12Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 11Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 10Manufacturing	Approved	None posted
Nov 23, 1993	Supplement 9Manufacturing	Approved	None posted
Oct 18, 1991	Supplement 4Manufacturing	Approved	None posted
Aug 7, 1990	Supplement 2Labeling	Approved	None posted
Aug 7, 1990	Supplement 3Manufacturing	Approved	None posted
Jan 31, 1990	Supplement 7Manufacturing	Approved	None posted
Jan 22, 1988	Supplement 5Manufacturing	Approved	None posted
Jan 22, 1988	Supplement 6Manufacturing	Approved	None posted
Jan 16, 1987	Supplement 1Manufacturing	Approved	None posted
Oct 24, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 18659
Drugs@FDA: Overview at FDA
Company: Mylan

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