Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022059
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYKERB LAPATINIB DITOSYLATE EQ 250MG 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
03/13/2007 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022059s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2017 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022059s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022059Orig1s022ltr.pdf
12/22/2014 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022059Orig1s021ltr.pdf
03/31/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022059s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022059Orig1s020ltr.pdf
06/21/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf
10/18/2013 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf
10/18/2013 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf
06/21/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf
03/02/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022059s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022059Orig1s013ltr.pdf
08/12/2011 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf
08/12/2011 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf
01/29/2010 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s007ltr.pdf
01/29/2010 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf
07/07/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022059s004ltr.pdf
01/29/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf
08/20/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s002ltr.pdf
04/27/2007 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/06/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022059s022lbl.pdf
03/31/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022059s020lbl.pdf
12/22/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf
10/18/2013 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf
10/18/2013 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf
06/21/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf
06/21/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf
03/02/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022059s013lbl.pdf
08/12/2011 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf
08/12/2011 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf
01/29/2010 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf
01/29/2010 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf
01/29/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf
07/07/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf
08/20/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s002lbl.pdf
04/27/2007 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf
03/13/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf

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