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Generated: February 15, 2019

DrugPatentWatch Database Preview

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
Applicant:Hoffmann-la Roche
Ingredient:saquinavir mesylate
Formulation / Manufacturing:see details
Pharmacology for NDA: 021785
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:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Dec 17, 2004TE:RLD:Yes

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