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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 004054

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NDA 004054 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 004054

Tradename:	SULFADIAZINE
Applicant:	Lederle
Ingredient:	sulfadiazine
Patents:	0

Medical Subject Heading (MeSH) Categories for 004054

Anti-Infective Agents
Antiprotozoal Agents
Coccidiostats

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	250MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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