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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 084964

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NDA 084964 describes SULFASALAZINE, which is a drug marketed by Nuvo Pharms Inc, Watson Labs, Chartwell, Epic Pharma Llc, Rising, Sun Pharm Industries, and Superpharm, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the SULFASALAZINE profile page.

The generic ingredient in SULFASALAZINE is sulfasalazine. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.

Summary for 084964

Tradename:	SULFASALAZINE
Applicant:	Watson Labs
Ingredient:	sulfasalazine
Patents:	0

Medical Subject Heading (MeSH) Categories for 084964

Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Gastrointestinal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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