Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021743
Company: OSI PHARMS
Company: OSI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TARCEVA | ERLOTINIB HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
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 |