Last Updated: September 24, 2026

Details for New Drug Application (NDA): 018785

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NDA 018785 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 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 018785

Tradename:	ALLOPURINOL
Applicant:	Watson Labs
Ingredient:	allopurinol
Patents:	0

Medical Subject Heading (MeSH) Categories for 018785

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:	Sep 28, 1984	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Sep 28, 1984	TE:		RLD:	No

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