FDA.reportPublic FDA data

Application 021743

Type
NDA
Sponsor
OSI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TARCEVAERLOTINIB HYDROCHLORIDETABLET;ORALEQ 25MG BASEYesNo
002TARCEVAERLOTINIB HYDROCHLORIDETABLET;ORALEQ 100MG BASEYesNo
003TARCEVAERLOTINIB HYDROCHLORIDETABLET;ORALEQ 150MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-062TARCEVAerlotinib hydrochlorideGenentech, Inc.NDACurrent
50242-063TARCEVAerlotinib hydrochlorideGenentech, Inc.NDACurrent
50242-064TARCEVAerlotinib hydrochlorideGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47287SUPPL2017-02-22
45565SUPPL2016-10-20
45552SUPPL2016-10-18
45489SUPPL2016-09-30
6100SUPPL2016-06-06
16292SUPPL2016-06-02
6099SUPPL2016-05-24
37567SUPPL2016-05-23
16291SUPPL2015-04-29
6098SUPPL2015-04-29
51719SUPPL2014-06-23
37566SUPPL2014-04-16
6097SUPPL2014-04-16
28504SUPPL2013-05-16
16290SUPPL2013-05-14
16289SUPPL2012-04-20
6096SUPPL2012-04-19
6095SUPPL2010-04-20
6094SUPPL2010-04-20
16288SUPPL2010-04-19
16287SUPPL2010-04-19
37565SUPPL2009-05-13
28503SUPPL2009-05-05
37564SUPPL2008-09-25
6093SUPPL2008-09-23
37563SUPPL2008-09-19
28502SUPPL2008-09-16
28501SUPPL2008-09-16
6092SUPPL2007-05-07
37562SUPPL2007-05-01
37561SUPPL2005-11-03
28500SUPPL2005-11-03
42294ORIG2005-03-28
28499ORIG2004-12-02
37560ORIG2004-11-18
63910ORIG1900-01-01
52478SUPPL1900-01-01
52477SUPPL1900-01-01
51718SUPPL1900-01-01