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FDA Drug Application 020591 by ABBVIE

Application Number020591
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/1996N       
AP010/22/1997SCS       
AP09/3/1999SCM       
AP03/1/2000SCM       
AP07/14/2000SCM       
AP05/31/2002SCM       
AP08/20/2002SCS       
AP02/29/2008SLR19356011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020591s011ltr.pdf 3/4/2008
AP08/29/2011SLR29926012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf 8/29/2011
AP08/29/2011SLR29934012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s012ltr.pdf 8/31/2011
AP03/5/2009SLR21962016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020591s016ltr.pdf 3/6/2009
AP09/14/2011SLR29995018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s018ltr.pdf 9/16/2011
AP09/14/2011SLR30016018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s018lbl.pdf 9/16/2011
AP011/14/2011SLR30574019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s019lbl.pdf 11/14/2011
AP011/14/2011SLR30603019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s019ltr.pdf 11/16/2011
AP01/23/2012SLR31487020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf 1/23/2012
AP01/23/2012SLR31575020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf 1/30/2012
AP09/12/2012SLR33747021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020591Orig1s021ltr.pdf 9/14/2012
AP09/12/2012SLR33760021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020591s021lbl.pdf 9/14/2012
AP010/20/2014SCM       
AP01/5/2015SCM       
AP012/24/2014SLR41447025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020591Orig1s025ltr.pdf 12/30/2014
AP012/24/2014SLR41554025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf 1/8/2015
AP01/29/2016SLR45061026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s026ltr.pdf 2/1/2016
AP01/29/2016SLR45084026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s026lbl.pdf 2/2/2016
AP07/12/2016SLR46523027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591Orig1s027lbledt.pdf 7/13/2016
AP07/12/2016SLR46815027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s027ltr.pdf 8/19/2016




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