Allopurinol

ANDA 70150, held by Puracap Pharm. Allopurinol.

As of Nov 15, 2026, ANDA 70150 (Allopurinol), held by Puracap Pharm, was first approved by FDA on Dec 10, 1985, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 10, 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 10, 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


Jul 29, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Mar 13, 2001	Supplement 9Manufacturing	Approved	None posted
Jun 2, 1993	Supplement 8Labeling	Approved	None posted
Jan 14, 1987	Supplement 6Manufacturing	Approved	None posted
Jul 16, 1986	Supplement 3Manufacturing	Approved	None posted
Jul 16, 1986	Supplement 4Manufacturing	Approved	None posted
May 20, 1986	Supplement 2Manufacturing	Approved	None posted
Feb 25, 1986	Supplement 1Manufacturing	Approved	None posted
Dec 10, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70150
Drugs@FDA: Overview at FDA
Company: PuraCap 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