Lopurin

Manages signs and symptoms of primary or secondary gout (acute attacks, tophi, joint…. ANDA 71587, held by Dr Reddys. Allopurinol.

As of Nov 15, 2026, ANDA 71587 (Lopurin), held by Dr Reddys, was first approved by FDA on Apr 2, 1987, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 2, 1987
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Allopurinol Tablets 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 and in…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 2, 1987	Original application	Approved	None posted

Products

2 strengths and forms


Lopurin300MG · tablet;oral	Allopurinol	Rx
Lopurin100MG · tablet;oral	Allopurinol	Rx

All 11 submissions, including labeling and manufacturing supplements


Jul 21, 2026	Supplement 16Labeling · Standard review	Approved	None posted
Jul 8, 1997	Supplement 10Manufacturing	Approved	None posted
Oct 18, 1993	Supplement 9Manufacturing	Approved	None posted
Jun 14, 1988	Supplement 8Labeling	Approved	None posted
Apr 22, 1988	Supplement 3Manufacturing	Approved	None posted
Apr 22, 1988	Supplement 4Manufacturing	Approved	None posted
Apr 22, 1988	Supplement 5Manufacturing	Approved	None posted
Apr 22, 1988	Supplement 6Labeling	Approved	None posted
Feb 23, 1988	Supplement 7Labeling	Approved	None posted
Jul 16, 1987	Supplement 1Manufacturing	Approved	None posted
Apr 2, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71587
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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