Last Updated: May 3, 2026

Details for New Drug Application (NDA): 021785

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NDA 021785 describes INVIRASE, which is a drug marketed by Hoffmann La Roche and Hoffmann-la Roche and is included in two NDAs. Additional details are available on the INVIRASE profile page.

The generic ingredient in INVIRASE is saquinavir mesylate. There is one drug master file entry for this compound. Additional details are available on the saquinavir mesylate profile page.

Summary for 021785

Tradename:	INVIRASE
Applicant:	Hoffmann-la Roche
Ingredient:	saquinavir mesylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Dec 17, 2004	TE:		RLD:	Yes

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