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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021743
Company: OSI PHARMS

Products on NDA 021743

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021743

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-Patient Package Insert, Labeling-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

Labels for NDA 021743

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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf
09/28/2016	SUPPL-26	Labeling-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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