← FDA DRUG APPROVALS

FDA NDA · NDA201292

GILOTRIF

afatinib

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA201292
TYPE
NDA
ORIGINAL APPROVAL
2013-07-12
LATEST ACTION
2022-04-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GILOTRIF · ReferencePrescription
AFATINIB DIMALEATE EQ 30MG BASE · TABLET · ORAL
GILOTRIF · ReferencePrescription
AFATINIB DIMALEATE EQ 40MG BASE · TABLET · ORAL
GILOTRIF · ReferencePrescription
AFATINIB DIMALEATE EQ 20MG BASE · TABLET · ORAL

Approval history

2022-04-07Efficacy · Supplement 17 · priority — Letter ↗AP
2019-10-11Labeling · Supplement 15 · standard — Letter ↗AP
2018-01-12Efficacy · Supplement 14 · priority — Label ↗AP
2017-11-06Labeling · Supplement 12 · standard — Label ↗AP
2016-10-04Labeling · Supplement 10 · standard — Label ↗AP
2016-04-20Labeling · Supplement 9 · standard — Letter ↗AP
2016-04-15Efficacy · Supplement 7 · standard — Label ↗AP
2015-12-28Labeling · Supplement 8 · standard — Letter ↗AP
2015-11-09Efficacy · Supplement 6 · standard — Letter ↗AP
2014-07-31Manufacturing (CMC) · Supplement 3 · priorityAP
2013-11-21Labeling · Supplement 2 · standard — Label ↗AP
2013-07-23Labeling · Supplement 1 · standard — Label ↗AP
2013-07-12Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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