Last Updated: November 8, 2026

Details for New Drug Application (NDA): 090637

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NDA 090637 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Aurobindo Pharma Ltd, Chartwell, Harman Finochem, Hetero Labs Ltd V, Ipca Labs Ltd, Lupin, Mutual Pharm, Mylan, Northstar Hlthcare, Ph Health, Puracap Pharm, Purepac Pharm, Regcon Holdings, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Gland, and Hikma, and is included in thirty-one NDAs. It is available from forty-two suppliers. Additional details are available on the ALLOPURINOL profile page.

The generic ingredient in ALLOPURINOL is allopurinol sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.

Summary for 090637

Tradename:	ALLOPURINOL
Applicant:	Ipca Labs Ltd
Ingredient:	allopurinol
Patents:	0

Medical Subject Heading (MeSH) Categories for 090637

Antimetabolites
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 16, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Mar 16, 2011	TE:		RLD:	No

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