Last Updated: November 9, 2026

Details for New Drug Application (NDA): 074285

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NDA 074285 describes DIFLUNISAL, which is a drug marketed by Ani Pharms, Dastech Intl, Heritage Pharma, Purepac Pharm, Teva, Watson Labs, and Zydus Pharms, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the DIFLUNISAL profile page.

The generic ingredient in DIFLUNISAL is diflunisal. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the diflunisal profile page.

Summary for 074285

Tradename:	DIFLUNISAL
Applicant:	Purepac Pharm
Ingredient:	diflunisal
Patents:	0

Medical Subject Heading (MeSH) Categories for 074285

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 7, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 7, 1996	TE:		RLD:	No

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