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FDA Drug Application 021180 by JANSSEN PHARMS

Application Number021180
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/20/2001N3074000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_Ortho%20EVRA_Approv.pdf 11/20/2001
AP011/20/2001N3075000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21180lbl.pdf 11/20/2001
AP011/20/2001N3076000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_ORTHO.cfm 11/20/2001
AP011/20/2001N14944000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110402.htm 9/22/2006
AP03/4/2002SCS20415001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s001_ORTHO EVRA.pdf 8/1/2008
AP08/9/2002SCM20414002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s002_ORTHO EVRA.pdf 8/1/2008
AP011/14/2002SCM14437003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s003_OrthoTOC.cfm 7/11/2006
AP010/2/2002SCM14438004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s004_OrthoTOC.cfm 7/11/2006
AP06/18/2002SCS16862005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21180_S005_OrthoEvraTOC.cfm 6/29/2007
AP02/4/2004SLR20360008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021180_s008_ORTHO EVRA.pdf 7/31/2008
AP02/4/2004SLR7760008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180slr008ltr.pdf 3/2/2004
AP011/24/2004SCS10676014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180s014ltr.pdf 12/2/2004
AP05/6/2005SLR11621015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s015ltr.pdf 5/17/2005
AP05/6/2005SLR11649015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf 5/17/2005
AP011/10/2005SLR13045019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s019lbl.pdf 11/10/2005
AP011/10/2005SLR13113019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s019ltr.pdf 11/18/2005
AP05/17/2006SLR14139020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s020LTR.pdf 5/21/2006
AP09/20/2006SLR14896022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf 9/20/2006
AP09/20/2006SLR14897022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s022ltr.pdf 9/20/2006
AP01/18/2008SLR18914026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s026lbl.pdf 1/18/2008
AP010/30/2008SLR21126028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf 11/3/2008
AP010/30/2008SLR21166028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf 11/7/2008
AP07/29/2009S23175029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf 8/13/2009
AP07/29/2009S23792029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s029ltr.pdf 11/10/2009
AP010/30/2008SLR21167030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf 11/7/2008
AP010/30/2008SLR21127030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf 11/3/2008
AP010/30/2008SLR21128031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,%20s030,%20s031ltr.pdf 11/3/2008
AP010/30/2008SLR21168031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf 11/7/2008
AP09/11/2009SLR23395033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf 9/17/2009
AP09/11/2009SLR23791033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s033ltr.pdf 11/10/2009
AP012/1/2009SLR24164034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf 12/2/2009
AP012/1/2009SLR24617034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s034ltr.pdf 1/25/2010
AP04/13/2010SLR25276035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021180s035ltr.pdf 4/19/2010
AP04/13/2010SLR25298035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf 4/19/2010
AP04/12/2013SCM       
AP07/26/2011SLR29624038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s038ltr.pdf 7/28/2011
AP07/26/2011SLR29772038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s038lbl.pdf 8/12/2011
AP03/23/2011SLR28348039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s039ltr.pdf 3/25/2011
AP03/23/2011SLR28386039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s039lbl.pdf 3/28/2011
AP012/28/2011SLR31304040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf 12/28/2011
AP012/28/2011SLR31320040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s040ltr.pdf 1/3/2012
AP04/12/2013SCM       
AP08/22/2012SLR33539043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf 8/22/2012
AP08/22/2012SLR33548043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021180Orig1s043ltr.pdf 8/24/2012
AP07/1/2013SLR36435044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021180Orig1s044ltr.pdf 7/3/2013
AP07/1/2013SLR36441044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021180s044lbl.pdf 7/3/2013
AP04/11/2014SLR39037046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021180Orig1s046ltr.pdf 4/14/2014
AP04/11/2014SLR39038046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf 4/14/2014
AP010/22/2015SLR44285047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021180Orig1s047ltr.pdf 10/23/2015
AP010/22/2015SLR44294047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021180s047lbl.pdf 10/26/2015




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