Allopurinol

ANDA 70466, held by Mutual Pharm. Allopurinol.

As of Nov 15, 2026, ANDA 70466 (Allopurinol), held by Mutual Pharm, was first approved by FDA on Dec 24, 1985, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1985
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Allopurinol100MG · tablet;oral	Allopurinol	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 15Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 14Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 13Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 10Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 12Manufacturing	Approved	None posted
Mar 4, 1988	Supplement 8Manufacturing	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 70466
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