Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201292
Company: BOEHRINGER INGELHEIM
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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