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GILOTRIF

NDA · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2013-07-12

Drug application

FDA Application #

NDA201292

Application type

New Drug Application

Brand name

GILOTRIF

Generic name

AFATINIB

Active ingredients

AFATINIB DIMALEATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

BOEHRINGER INGELHEIM

Manufacturer

Boehringer Ingelheim Pharmaceuticals, Inc.

First approval

2013-07-12

Source

Authoritative

Drugs@FDA application overview

Machine

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