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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 21743

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

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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