Allopurinol

ANDA 70467, held by Mutual Pharm. Allopurinol.

As of Nov 15, 2026, ANDA 70467 (Allopurinol), held by Mutual Pharm, was first approved by FDA on Dec 24, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1985
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 24, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Allopurinol300MG · tablet;oral	Allopurinol	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 19Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 18Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 17Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 14Manufacturing	Approved	None posted
Apr 26, 1991	Supplement 11Manufacturing	Approved	None posted
May 18, 1988	Supplement 10Labeling	Approved	None posted
Jan 15, 1988	Supplement 8Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 7Manufacturing	Approved	None posted
Sep 5, 1986	Supplement 5Manufacturing	Approved	None posted
Aug 6, 1986	Supplement 4Manufacturing	Approved	None posted
Dec 24, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70467
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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