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FDA Drug Application 103795 by IMMUNEX

Application Number103795
Application Type Biologic License Application
Sponsor ApplicantIMMUNEX
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
AP011/2/1998N102480000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080536.htm 9/22/2004
AP011/2/1998N102490000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/etanimm110298L.htm 9/22/2004
AP011/2/1998N102500000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/etanimm110298lb.pdf 9/22/2004
AP011/2/1998N207340000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm 9/4/2008
AP011/2/1998N239540000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088590.pdf 11/18/2009
AP011/2/1998N310410000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm 12/20/2011
AP05/27/1999S102461001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/etanimm052799L.htm 9/22/2004
AP05/27/1999S102471001   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080578.htm 9/22/2004
AP06/6/2000S102441004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/etanimm060600L.htm 9/22/2004
AP06/6/2000S102451004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/etanimm060600lb.txt 9/22/2004
AP01/15/2002S       
AP01/15/2002S102545034   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080570.htm 9/22/2004
AP01/15/2002S102555034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/etanimm011502L.htm 9/22/2004
AP01/15/2002S102565034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm011502LB.pdf 9/22/2004
AP09/12/2002S102575051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/etanimm091202L.pdf 9/22/2004
AP09/12/2002S102585051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202LB.pdf 9/22/2004
AP09/12/2002S102595051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202PLB.pdf 9/22/2004
AP07/24/2003S68855055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5055ltr.pdf 11/5/2003
AP07/24/2003S68865097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5097ltr.pdf 11/5/2003
AP07/24/2003S203925097   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795_S5097_ENBREL.pdf 7/31/2008
AP010/9/2003S68875099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5099ltr.pdf 11/5/2003
AP08/21/2003S68885102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5102ltr.pdf 11/6/2003
AP08/21/2003S107435102   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795-5102_Enbrel.cfm 12/7/2004
AP06/5/2003S102525109   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/etanimm060503L.htm 9/22/2004
AP06/5/2003S102535109   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/etanimm060503LB.pdf 9/22/2004
AP06/5/2003S203915109   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795_S5109_ENBREL.pdf 7/31/2008
AP010/17/2003S68895110   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5110ltr.pdf 11/6/2003
AP07/24/2003S68905123   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5123ltr.pdf 11/6/2003
AP07/24/2003S132275123   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795s5123_EnbrelTOC.cfm 12/6/2005
AP011/25/2003S83195125   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5125ltr.pdf 4/8/2004
AP04/30/2004S91865149   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103795_5149ltr.pdf 6/8/2004
AP04/30/2004S91955149   http://www.accessdata.fda.gov/drugsatfda_docs/label/biologics/103795_5149ppi.pdf 4/30/2004
AP09/24/2004S104395162   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5162lbl.pdf 10/21/2004
AP09/24/2004S104635162   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103795_5162LTR.pdf 10/26/2004
AP09/27/2004S105315184   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103795s5184ltr.pdf 11/8/2004
AP09/27/2004S105585184   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5184lbl.pdf 11/8/2004
AP05/27/2005S117585191   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5191ltr.pdf 6/7/2005
AP05/27/2005S117615191   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5191lbl.pdf 6/7/2005
AP06/28/2005S120365225   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795s5225ltr.pdf 7/21/2005
AP06/28/2005S120375225   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795s5225lbl.pdf 7/21/2005
AP07/28/2005S125605229   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5229ltr.pdf 8/8/2005
AP07/28/2005S125715229   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5229lbl.pdf 8/8/2005
AP05/17/2006S       
AP01/24/2006S       
AP02/7/2006S       
AP02/16/2006S       
AP03/2/2006S       
AP03/23/2006S       
AP03/2/2006S       
AP04/4/2006S       
AP03/21/2006S       
AP04/4/2006S       
AP04/13/2006S       
AP06/16/2006S       
AP06/14/2006S147755286   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103795s5286lbl.pdf 8/31/2006
AP04/26/2006S       
AP09/25/2006S       
AP011/2/2006S       
AP01/12/2007S       
AP012/1/2006S       
AP012/1/2006S       
AP011/2/2006S       
AP011/9/2006S       
AP012/8/2006S       
AP02/1/2007S160115322   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103795s5322lbl.pdf 3/14/2007
AP02/1/2007S160175322   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103795s5322ltr.pdf 3/15/2007
AP06/21/2007S       
AP06/29/2007S       
AP08/2/2007S       
AP010/31/2007S       
AP03/21/2008S199005356   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/enbrel_pi.pdf 5/29/2008
AP06/23/2008S207565359   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103795s5359lbl.pdf 9/8/2008
AP06/23/2008S207585359   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103795s5359ltr.pdf 9/9/2008
AP06/3/2010S258575391   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf 6/29/2010
AP06/3/2010S258565397   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf 6/29/2010
AP06/3/2010S258555400   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf 6/29/2010
AP011/18/2009S241815415   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103795s5415ltr.pdf 12/3/2009
AP011/18/2009S275155415   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103795s5415lbl.pdf 1/11/2011
AP01/25/2011S276205431   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5431ltr.pdf 1/27/2011
AP07/29/2010S260915437   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5437ltr.pdf 8/2/2010
AP09/29/2010S266725443   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5443ltr.pdf 10/19/2010
AP010/13/2010S268915445   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5445ltr.pdf 11/4/2010
AP09/7/2011S299805475   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5475ltr.pdf 9/13/2011
AP012/4/2012SLR345435503   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf 12/5/2012
AP012/4/2012SLR345585503   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5503ltr.pdf 12/5/2012
AP012/10/2012SLR346095507   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5507ltr.pdf 12/13/2012
AP012/10/2012SLR346605507   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf 12/14/2012
AP012/10/2012SLR346615507   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507mg.pdf 12/14/2012
AP011/15/2013SLR378375531   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103795Orig1s5531ltr.pdf 11/18/2013
AP011/15/2013SLR378955531   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103795s5531lbl.pdf 11/22/2013
AP03/20/2015S422585532   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5532lbl.pdf 3/24/2015
AP03/25/2015SLR422885548   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103795Orig1s5548ltr.pdf 3/26/2015
AP03/25/2015SLR422985548   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5548lbl.pdf 3/26/2015




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