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Details for New Drug Application (NDA): 020628

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NDA 020628 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 NDA: 020628

Tradename:
INVIRASE
Applicant:
Hoffmann La Roche
Ingredient:
saquinavir mesylate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020628

Suppliers and Packaging for NDA: 020628

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVIRASE
saquinavir mesylate
CAPSULE;ORAL 020628 NDA Genentech, Inc. 0004-0245 0004-0245-15 270 CAPSULE in 1 BOTTLE, PLASTIC (0004-0245-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Dec 6, 1995TE:RLD:Yes
Regulatory Exclusivity Expiration:May 30, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Nov 30, 2015
Regulatory Exclusivity Use:REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST

Expired Orange Book Patents for NDA: 020628

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
INVIRASE
saquinavir mesylate
CAPSULE;ORAL020628-001Dec 6, 19955,196,438*PED► subscribe
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