Allopurinol

ANDA 90637, held by Ipca Labs Ltd. Allopurinol.

As of Nov 15, 2026, ANDA 90637 (Allopurinol), held by Ipca Labs Ltd, was first approved by FDA on Mar 16, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 16, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Allopurinol100MG · tablet;oral	Allopurinol	Discontinued
Allopurinol300MG · tablet;oral	Allopurinol	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 29, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jul 30, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Mar 16, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90637
Drugs@FDA: Overview at FDA
Company: Ipca Laboratories

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