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ORKAMBI

NDA · New Drug Application · Sponsor: VERTEX PHARMS INC · Approved 2018-08-07

Drug application

FDA Application #

NDA211358

Application type

New Drug Application

Brand name

ORKAMBI

Generic name

LUMACAFTOR AND IVACAFTOR

Active ingredients

IVACAFTOR; LUMACAFTOR

Dosage form

GRANULE

Route

ORAL

Marketing status

Prescription

Sponsor

VERTEX PHARMS INC

Manufacturer

Vertex Pharmaceuticals Incorporated

First approval

2018-08-07

Source

Authoritative

Drugs@FDA application overview

Machine

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