← FDA Drug Approvals (Drugs@FDA)

SYMDEKO (COPACKAGED)

NDA · New Drug Application · Sponsor: VERTEX PHARMS INC · Approved 2018-02-12

Drug application

FDA Application #

NDA210491

Application type

New Drug Application

Brand name

SYMDEKO (COPACKAGED)

Generic name

TEZACAFTOR AND IVACAFTOR

Active ingredients

IVACAFTOR; IVACAFTOR, TEZACAFTOR

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

VERTEX PHARMS INC

Manufacturer

Vertex Pharmaceuticals Incorporated

First approval

2018-02-12

Source

Authoritative

Drugs@FDA application overview

Machine

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