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KALYDECO

NDA · New Drug Application · Sponsor: VERTEX PHARMS · Approved 2012-01-31

Drug application

FDA Application #

NDA203188

Application type

New Drug Application

Brand name

KALYDECO

Generic name

IVACAFTOR

Active ingredients

IVACAFTOR

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

VERTEX PHARMS

Manufacturer

Vertex Pharmaceuticals Incorporated

First approval

2012-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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