Allopurinol

ANDA 70268, held by Aiping Pharm Inc. Allopurinol.

As of Nov 15, 2026, ANDA 70268 (Allopurinol), held by Aiping Pharm Inc, 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
Allopurinol100MG · tablet;oral	Allopurinol	Discontinued

All 12 submissions, including labeling and manufacturing supplements


May 9, 2001	Supplement 13Manufacturing	Approved	None posted
Apr 26, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 11Manufacturing	Approved	None posted
Dec 20, 1994	Supplement 10Manufacturing	Approved	None posted
May 11, 1990	Supplement 9Labeling	Approved	None posted
Jan 4, 1989	Supplement 7Manufacturing	Approved	None posted
Jan 26, 1988	Supplement 5Manufacturing	Approved	None posted
Jan 26, 1988	Supplement 6Manufacturing	Approved	None posted
May 3, 1987	Supplement 3Manufacturing	Approved	None posted
May 3, 1987	Supplement 4Manufacturing	Approved	None posted
Mar 24, 1987	Supplement 2Manufacturing	Approved	None posted
Dec 31, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70268
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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