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FDA Drug Application 125084 by IMCLONE

Application Number125084
Application Type Biologic License Application
Sponsor ApplicantIMCLONE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/12/2004N10184000   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125084_erbitux_toc.cfm 9/13/2004
AP02/12/2004N11416000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113714.htm 4/15/2005
AP02/12/2004N7696000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125084lbl.pdf 2/12/2004
AP02/12/2004N7697000Questions and Answers  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113715.htm 2/11/2004
AP02/12/2004N8318000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084ltr.pdf 4/8/2004
AP06/18/2004S95330001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084-0001ltr.pdf 6/24/2004
AP09/1/2005S274330030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/0125084_s030_erbitux.pdf 1/4/2011
AP09/1/2005S127540030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125084_0030lbl.pdf 9/8/2005
AP09/1/2005S127550030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125084_0030ltr.pdf 9/8/2005
AP03/1/2006S139680046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046LTR.pdf 4/21/2006
AP03/1/2006S139750046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf 4/21/2006
AP03/1/2006S141620076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf 5/23/2006
AP03/1/2006S141690076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046, 125084s076, 125084s077LTR.pdf 5/25/2006
AP07/22/2009S231430167   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s167lbl.pdf 8/6/2009
AP07/22/2009S231600167   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125084s0167ltr.pdf 8/12/2009
AP010/2/2007S18184103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125084s103lbl.pdf 10/5/2007
AP010/2/2007S18199103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125084s103ltl.pdf 10/10/2007
AP010/2/2007S30858103   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125084Orig1s103.pdf 12/2/2011
AP09/12/2008S20784139   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125084s139ltr.pdf 9/16/2008
AP011/7/2011S30531153   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125084s153lbl.pdf 11/7/2011
AP011/7/2011S30532153   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125084s153ltr.pdf 11/8/2011
AP07/17/2009S23002168   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf 7/20/2009
AP07/6/2012SE533074225   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf 7/6/2012
AP07/6/2012SE533099225   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s225ltr.pdf 7/9/2012
AP01/24/2012S31604228   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s228ltr.pdf 1/31/2012
AP01/24/2012S32165228   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s0228lbl.pdf 3/20/2012
AP01/19/2012S31605229   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s229ltr.pdf 1/31/2012
AP01/19/2012S31801229   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s229lbl.pdf 2/16/2012
AP03/4/2013SLR35347242   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125084Orig1s242ltr.pdf 3/5/2013
AP03/4/2013SLR35392242   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125084s242lbl.pdf 3/8/2013
AP04/10/2015SLR42516262   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s262ltr.pdf 4/13/2015
AP04/10/2015SLR42520262   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s262lbl.pdf 4/14/2015
AP03/11/2015SLR42114263   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s263ltr.pdf 3/12/2015
AP03/11/2015SLR42119263   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s063lbl.pdf 3/12/2015
AP010/11/2016SLR47352265   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125084Orig1s265ltr.pdf 10/14/2016




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