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VITRAKVI

NDA · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2018-11-26

Drug application

FDA Application #

NDA210861

Application type

New Drug Application

Brand name

VITRAKVI

Generic name

LAROTRECTINIB

Active ingredients

LAROTRECTINIB SULFATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

BAYER HLTHCARE

Manufacturer

Loxo Oncology, Inc.

First approval

2018-11-26

Source

Authoritative

Drugs@FDA application overview

Machine

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