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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 020828

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NDA 020828 describes FORTOVASE, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the FORTOVASE profile page.

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

Summary for 020828

Tradename:	FORTOVASE
Applicant:	Hoffmann La Roche
Ingredient:	saquinavir
Patents:	0

Medical Subject Heading (MeSH) Categories for 020828

Cytochrome P-450 CYP3A Inhibitors
HIV Protease Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 7, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020828

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997	⤷ Get Started Free	⤷ Get Started Free
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997	⤷ Get Started Free	⤷ Get Started Free
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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