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. It is available from two suppliers. 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. Two suppliers are listed 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021785

Mechanism of Action	HIV Protease Inhibitors Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 021785

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INVIRASE	saquinavir mesylate	TABLET;ORAL	021785	NDA	Genentech, Inc.	0004-0244	0004-0244-51	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0244-51)
INVIRASE	saquinavir mesylate	TABLET;ORAL	021785	NDA	State of Florida DOH Central Pharmacy	53808-0674	53808-0674-1	30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0674-1)

Profile for product number 001

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

Expired US Patents for NDA 021785

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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