← FDA Drug Approvals (Drugs@FDA)

TRIKAFTA (COPACKAGED)

NDA · New Drug Application · Sponsor: VERTEX PHARMS INC · Approved 2019-10-21

Drug application

FDA Application #

NDA212273

Application type

New Drug Application

Brand name

TRIKAFTA (COPACKAGED)

Generic name

ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Active ingredients

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

VERTEX PHARMS INC

Manufacturer

Vertex Pharmaceuticals Incorporated

First approval

2019-10-21

Source

Authoritative

Drugs@FDA application overview

Machine

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