Last Updated: November 8, 2026

Details for New Drug Application (NDA): 040349

« Back to Dashboard

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 is one drug master file entry 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.