Allopurinol

ANDA 70269, held by Sandoz. Allopurinol.

As of Nov 15, 2026, ANDA 70269 (Allopurinol), held by Sandoz, was first approved by FDA on Dec 31, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 31, 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 31, 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 11, 2024	Supplement 19Labeling · Standard review	Approved	None posted
May 9, 2001	Supplement 15Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 14Manufacturing	Approved	None posted
Dec 20, 1994	Supplement 13Manufacturing	Approved	None posted
Jan 26, 1988	Supplement 11Manufacturing	Approved	None posted
Jan 26, 1988	Supplement 10Manufacturing	Approved	None posted
Jul 15, 1987	Supplement 9Manufacturing	Approved	None posted
Jul 15, 1987	Supplement 5Manufacturing	Approved	None posted
May 8, 1987	Supplement 4Manufacturing	Approved	None posted
Aug 27, 1986	Supplement 2Manufacturing	Approved	None posted
Mar 11, 1986	Supplement 1Manufacturing	Approved	None posted
Dec 31, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70269
Drugs@FDA: Overview at FDA
Company: Sandoz

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