Last Updated: June 24, 2026

Details for New Drug Application (NDA): 219046

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NDA 219046 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 219046

Tradename:	SULFASALAZINE
Applicant:	Rising
Ingredient:	sulfasalazine
Patents:	0

Pharmacology for NDA: 219046

Medical Subject Heading (MeSH) Categories for 219046

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

Suppliers and Packaging for NDA: 219046

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFASALAZINE	sulfasalazine	TABLET;ORAL	219046	ANDA	Rising Pharma Holdings, Inc.	16571-261	16571-261-01	100 TABLET in 1 CONTAINER (16571-261-01)
SULFASALAZINE	sulfasalazine	TABLET;ORAL	219046	ANDA	Rising Pharma Holdings, Inc.	16571-261	16571-261-30	300 TABLET in 1 CONTAINER (16571-261-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 4, 2025	TE:	AB	RLD:	No

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