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FDA Drug Application 020528 by ABBVIE

Application Number020528
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/26/1996N14281000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP07/2/1997SE14304001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020528_s001ap.pdf 7/2/1997
AP09/24/1999SCM       
AP010/26/1999SCM       
AP04/5/2000SLR       
AP07/14/2000SCM       
AP02/2/2001SCS       
AP08/20/2002SCS       
AP02/6/2004SLR7796008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20528slr008ltr.pdf 3/3/2004
AP04/20/2010SLR25337012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020528s012ltr.pdf 4/23/2010
AP04/20/2010SLR25435012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020528s012lbl.pdf 5/3/2010
AP04/8/2009SLR22271016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020528s016lbl.pdf 4/16/2009
AP04/8/2009SLR22282016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020528s016ltr.pdf 4/16/2009
AP011/10/2011SLR30568017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s017ltr.pdf 11/14/2011
AP01/23/2012SLR31486018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf 1/23/2012
AP01/23/2012SLR31573018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s018ltr.pdf 1/30/2012
AP09/14/2011SLR29997019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s019ltr.pdf 9/16/2011
AP09/14/2011SLR30015019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020528s019lbl.pdf 9/16/2011
AP01/23/2012SLR31574020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf 1/30/2012
AP01/23/2012SLR32034020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf 3/6/2012
AP09/11/2012SLR33749021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528Orig1s021ltr.pdf 9/14/2012
AP09/11/2012SLR33763021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s021lbl.pdf 9/14/2012
AP06/13/2013SCM       
AP012/24/2014SLR41445023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020528Orig1s023ltr.pdf 12/30/2014
AP012/24/2014SLR41600023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020528s023lbl.pdf 1/9/2015
AP01/29/2016SLR45060024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020528Orig1s024ltr.pdf 2/1/2016
AP01/29/2016SLR45081024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf 2/2/2016




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