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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 018557

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NDA 018557 describes FANSIDAR, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the FANSIDAR profile page.

The generic ingredient in FANSIDAR is pyrimethamine; sulfadoxine. There are three drug master file entries for this compound. Additional details are available on the pyrimethamine; sulfadoxine profile page.

Summary for 018557

Tradename:	FANSIDAR
Applicant:	Roche
Ingredient:	pyrimethamine; sulfadoxine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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