Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021743
Company: OSI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TARCEVA ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription None Yes No
TARCEVA ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription None Yes No
TARCEVA ERLOTINIB HYDROCHLORIDE EQ 150MG 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
11/18/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021743lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21743ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-743_Tarceva.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/01/2016 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s027ltr.pdf
09/28/2016 SUPPL-26 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s026ltr.pdf
10/18/2016 SUPPL-25 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s025ltr.pdf
03/15/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/20/2016 SUPPL-23 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s023ltr.pdf
07/06/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/27/2015 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021743s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021743Orig2s021ltr.pdf
04/14/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021743s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021743Orig1s019ltr.pdf
05/14/2013 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021743s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021743Orig1s018ltr.pdf
04/17/2012 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021743s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021743s017ltr.pdf
04/16/2010 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021743s014,s016ltr.pdf
04/27/2009 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021743s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021743s015ltr.pdf
04/16/2010 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021743s014,s016ltr.pdf
09/19/2008 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s011ltr.pdf
09/12/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s008, s010ltr.pdf
09/12/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s008, s010ltr.pdf
04/27/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021743s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021743s007ltr.pdf
11/02/2005 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021743s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021743s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/18/2016 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf
09/28/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf
09/28/2016 SUPPL-26 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf
06/01/2016 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s027lbl.pdf
05/20/2016 SUPPL-23 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s023lbl.pdf
04/27/2015 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021743s021lbl.pdf
04/14/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021743s019lbl.pdf
05/14/2013 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021743s018lbl.pdf
04/17/2012 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021743s017lbl.pdf
04/16/2010 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf
04/16/2010 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf
04/27/2009 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021743s015lbl.pdf
09/19/2008 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s011lbl.pdf
09/12/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s010lbl.pdf
04/27/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021743s007lbl.pdf
11/02/2005 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021743s003lbl.pdf
11/18/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021743lbl.pdf

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