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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 075339

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NDA 075339 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 075339

Tradename:	SULFASALAZINE
Applicant:	Nuvo Pharms Inc
Ingredient:	sulfasalazine
Patents:	0

Pharmacology for NDA: 075339

Medical Subject Heading (MeSH) Categories for 075339

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

Suppliers and Packaging for NDA: 075339

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFASALAZINE	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	075339	ANDA	Sunrise Pharmaceutical, Inc.	11534-201	11534-201-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-01)
SULFASALAZINE	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	075339	ANDA	Sunrise Pharmaceutical, Inc.	11534-201	11534-201-07	300 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-201-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	500MG
Approval Date:	Jan 11, 2002	TE:	AB	RLD:	No

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