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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077353

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NDA 077353 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 Ltd, 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 thirty-eight 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. Four suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.

Summary for 077353

Tradename:	ALLOPURINOL
Applicant:	Chartwell
Ingredient:	allopurinol
Patents:	0

Pharmacology for NDA: 077353

Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for 077353

Antimetabolites
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants

Suppliers and Packaging for NDA: 077353

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALLOPURINOL	allopurinol	TABLET;ORAL	077353	ANDA	Chartwell RX, LLC	62135-516	62135-516-31	300 TABLET in 1 BOTTLE (62135-516-31)
ALLOPURINOL	allopurinol	TABLET;ORAL	077353	ANDA	Chartwell RX, LLC	62135-516	62135-516-90	90 TABLET in 1 BOTTLE (62135-516-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 8, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Sep 8, 2005	TE:	AB	RLD:	No

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