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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201292
Company: BOEHRINGER INGELHEIM

Summary Review

Products on NDA 201292

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GILOTRIF	AFATINIB DIMALEATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	No
GILOTRIF	AFATINIB DIMALEATE	EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	No
GILOTRIF	AFATINIB DIMALEATE	EQ 40MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201292

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2013	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2022	SUPPL-17	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201292s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201292Orig1s017ltr.pdf
10/11/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201292s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201292Orig1s015ltr.pdf
01/12/2018	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201292Orig1s014ltr.pdf
11/06/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201292s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201292Orig1s012ltr.pdf
10/04/2016	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s010ltr.pdf
04/20/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s009ltr.pdf
12/28/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201292Orig1s008ltr.pdf
04/15/2016	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s007ltr.pdf
11/09/2015	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201292Orig1s006ltr.pdf
07/31/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/21/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s002ltr.pdf
07/23/2013	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s001.pdf

Labels for NDA 201292

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2022	SUPPL-17	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201292s017lbl.pdf
10/11/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201292s015lbl.pdf
01/12/2018	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf
11/06/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201292s012lbl.pdf
10/04/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s010lbl.pdf
04/20/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s009lbl.pdf
04/15/2016	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s007lbl.pdf
12/28/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s008lbl.pdf
11/09/2015	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s006lbl.pdf
11/21/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s002lbl.pdf
07/23/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s001lbl.pdf
07/12/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s000lbl.pdf

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