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FDA Drug Application 125057 by ABBVIE INC

Application Number125057
Application Type Biologic License Application
Sponsor ApplicantABBVIE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/2002N79610000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080610.htm 3/16/2004
AP012/31/2002N79620000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm 3/16/2004
AP012/31/2002N79630000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm 3/16/2004
AP012/31/2002N239980000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088611.pdf 11/19/2009
AP012/31/2002N310400000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm 12/20/2011
AP07/30/2004S420950016   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125057Orig1s016.pdf 3/11/2015
AP07/30/2004S99480016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125057_0016ltr.pdf 8/6/2004
AP07/30/2004S99490016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf 8/6/2004
AP06/18/2004S97240023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/125057_0023ltr.pdf 7/7/2004
AP06/18/2004S369920023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125057Orig1s023.pdf 9/9/2013
AP010/3/2005S128490045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf 10/10/2005
AP010/3/2005S129160045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0045ltr.pdf 10/20/2005
AP010/3/2005S420650045   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s045.pdf 3/9/2015
AP010/3/2005S420640046   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s046.pdf 3/9/2015
AP010/3/2005S128500046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf 10/10/2005
AP010/3/2005S129150046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0046ltr.pdf 10/20/2005
AP02/16/2007S158970060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s060LTR.pdf 2/23/2007
AP02/16/2007S159080060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf 2/23/2007
AP08/28/2006S147760062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf 8/31/2006
AP011/9/2006S153470071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf 11/14/2006
AP011/9/2006S153590071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf 11/14/2006
AP02/27/2007S159670089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s089Ltr.pdf 3/6/2007
AP02/27/2007S159970089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf 3/7/2007
AP02/27/2007S356460089   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125057_S0089.pdf 4/9/2013
AP07/30/2007S174390094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf 7/31/2007
AP07/30/2007S174420094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s094ltr.pdf 8/1/2007
AP011/9/2006S153600095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf 11/14/2006
AP011/9/2006S153480095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf 11/14/2006
AP09/5/2007S177790108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf 9/7/2007
AP09/5/2007S177860108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s108_ltr.pdf 9/7/2007
AP01/18/2008S189590110   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s0110ltr.pdf 1/25/2008
AP01/18/2008S195490110   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf 3/27/2008
AP01/18/2008S221010110   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110TOC.cfm 3/24/2009
AP01/18/2008S221020110   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110_SumR.pdf 3/24/2009
AP02/21/2008S193010114   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s114ltr.pdf 2/26/2008
AP02/21/2008S193020114   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf 2/26/2008
AP011/18/2009S241840196   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125057s0196ltr.pdf 12/3/2009
AP011/18/2009S248370196   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf 2/23/2010
AP07/29/2010S260950213   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s0213ltr.pdf 8/3/2010
AP07/29/2010S451100213   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125057Orig1s0213.pdf 2/3/2016
AP02/25/2011S280570215   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf 3/4/2011
AP05/24/2012S327720278   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf 5/29/2012
AP05/24/2012S327770278   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s0278ltr.pdf 5/30/2012
AP03/14/2011S28353128   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s128ltr.pdf 3/25/2011
AP04/8/2010S25753161   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s161ltr.pdf 6/17/2010
AP09/29/2010S26673224   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s224ltr.pdf 10/19/2010
AP09/28/2012SE133936232   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf 10/2/2012
AP09/28/2012SE133951232   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057Orig1s232ltr.pdf 10/3/2012
AP07/13/2011S31349254   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s254ltr.pdf 1/5/2012
AP09/7/2011S29983255   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s255ltr.pdf 9/13/2011
AP012/13/2011S31348271   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s271ltr.pdf 1/5/2012
AP012/26/2011S32117276   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf 3/15/2012
AP012/26/2011S31347276   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s276ltr.pdf 1/5/2012
AP012/24/2014SCM41521280   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s280ltr.pdf 1/8/2015
AP012/24/2014SCM46731280   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125057Orig1s280.pdf 8/5/2016
AP05/13/2013SLR36046310   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf 5/13/2013
AP05/13/2013SLR36072310   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s310ltr.pdf 5/15/2013
AP04/24/2013SCM35871322   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf 4/29/2013
AP09/19/2013SLR37185327   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s327ltr.pdf 9/20/2013
AP09/19/2013SLR37202327   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf 9/24/2013
AP02/26/2014SLR38616355   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s355_replace_ltr.pdf 2/27/2014
AP02/26/2014SLR38622355   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf 2/27/2014
AP09/23/2014SE840599356   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s356ltr.pdf 9/25/2014
AP09/23/2014SE840625356   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf 9/26/2014
AP05/30/2014SLR39428366   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s366ltr.pdf 6/3/2014
AP05/30/2014SLR39438366   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf 6/3/2014
AP09/30/2014SE840690367   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s367ltr.pdf 10/2/2014
AP09/30/2014SE840699367   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf 10/2/2014
AP05/14/2014SLR39307368   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf 5/15/2014
AP05/14/2014SLR39327368   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s368ltr.pdf 5/20/2014
AP08/7/2014SCM46657381   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125057Orig1s381.pdf 7/28/2016
AP010/29/2014SLR       
AP09/9/2015SE843855393   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s393ltr.pdf 9/14/2015
AP011/23/2015SE844574394   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s394ltr.pdf 11/24/2015
AP011/23/2015SE844583394   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf 11/25/2015
AP011/23/2015SE845414394   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125057Orig1s394SumR.pdf 3/11/2016
AP06/30/2016SE846449397   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125057Orig1s397ltr.pdf 7/1/2016
AP06/30/2016SE846458397   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf 7/5/2016
AP010/17/2016SCM47393400   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf 10/19/2016




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