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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040091

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NDA 040091 describes SULFADIAZINE, which is a drug marketed by Abbvie, Chartwell Molecular, Epic Pharma Llc, Everylife, Impax Labs, Lederle, and Lilly, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the SULFADIAZINE profile page.

The generic ingredient in SULFADIAZINE is sulfadiazine sodium. There are nineteen drug master file entries for this compound. Additional details are available on the sulfadiazine sodium profile page.

Summary for 040091

Tradename:	SULFADIAZINE
Applicant:	Epic Pharma Llc
Ingredient:	sulfadiazine
Patents:	0

Pharmacology for NDA: 040091

Medical Subject Heading (MeSH) Categories for 040091

Anti-Infective Agents
Antiprotozoal Agents
Coccidiostats

Suppliers and Packaging for NDA: 040091

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFADIAZINE	sulfadiazine	TABLET;ORAL	040091	ANDA	EPIC PHARMA, LLC	42806-757	42806-757-60	60 TABLET in 1 BOTTLE (42806-757-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 29, 1994	TE:		RLD:	No

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