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KALYDECO

NDA · New Drug Application · Sponsor: VERTEX PHARMS INC · Approved 2015-03-17

Drug application

FDA Application #

NDA207925

Application type

New Drug Application

Brand name

KALYDECO

Generic name

IVACAFTOR

Active ingredients

IVACAFTOR

Dosage form

GRANULE

Route

ORAL

Marketing status

Prescription

Sponsor

VERTEX PHARMS INC

Manufacturer

Vertex Pharmaceuticals Incorporated

First approval

2015-03-17

Source

Authoritative

Drugs@FDA application overview

Machine

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