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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080084

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NDA 080084 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 080084

Tradename:	SULFADIAZINE
Applicant:	Chartwell Molecular
Ingredient:	sulfadiazine
Patents:	0

Pharmacology for NDA: 080084

Medical Subject Heading (MeSH) Categories for 080084

Anti-Infective Agents
Antiprotozoal Agents
Coccidiostats

Suppliers and Packaging for NDA: 080084

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFADIAZINE	sulfadiazine	TABLET;ORAL	080084	ANDA	Chartwell RX, LLC	62135-842	62135-842-60	60 TABLET in 1 BOTTLE (62135-842-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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