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PREZCOBIX

NDA · New Drug Application · Sponsor: JANSSEN PRODS · Approved 2015-01-29

Drug application

FDA Application #

NDA205395

Application type

New Drug Application

Brand name

PREZCOBIX

Generic name

DARUNAVIR ETHANOLATE AND COBICISTAT

Active ingredients

COBICISTAT; DARUNAVIR ETHANOLATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN PRODS

Manufacturer

Janssen Products, LP

First approval

2015-01-29

Source

Authoritative

Drugs@FDA application overview

Machine

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