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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040349

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NDA 040349 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 040349

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

Pharmacology for NDA: 040349

Medical Subject Heading (MeSH) Categories for 040349

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

Suppliers and Packaging for NDA: 040349

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFASALAZINE	sulfasalazine	TABLET;ORAL	040349	ANDA	Sunrise Pharmaceutical, Inc.	11534-200	11534-200-01	100 TABLET in 1 BOTTLE (11534-200-01)
SULFASALAZINE	sulfasalazine	TABLET;ORAL	040349	ANDA	Sunrise Pharmaceutical, Inc.	11534-200	11534-200-04	500 TABLET in 1 BOTTLE (11534-200-04)

Profile for product number 001

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

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