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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 078390

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NDA 078390 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Chartwell, Endo Operations, Harman Finochem, Hetero Labs Ltd V, Indoco, Ipca Labs Ltd, Lupin Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Gland Pharma Ltd, and Hikma, and is included in thirty 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 twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.

Summary for 078390

Tradename:	ALLOPURINOL
Applicant:	Sun Pharm Inds Inc
Ingredient:	allopurinol
Patents:	0

Medical Subject Heading (MeSH) Categories for 078390

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:	Aug 30, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Aug 30, 2007	TE:		RLD:	No

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