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FDA Drug Application 021656 by ABBVIE

Application Number021656
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/5/2004N10554000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21656ltr.pdf 11/8/2004
AP011/5/2004N10568000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf 11/8/2004
AP011/5/2004N13978000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021656s000_TricorTOC.cfm 4/21/2006
AP09/10/2007SLR17976004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021656s004,s011ltr.pdf 9/25/2007
AP09/10/2007SLR       
AP04/15/2008SLR19649013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021249s019,021656s013ltr.pdf 4/16/2008
AP010/20/2010SLR26728019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf 10/21/2010
AP010/20/2010SLR26731019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021656s019ltr.pdf 10/25/2010
AP09/22/2011SLR30069020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf 9/23/2011
AP09/22/2011SLR30083020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021656s020ltr.pdf 9/26/2011
AP02/5/2013SLR35088023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf 2/6/2013
AP02/5/2013SLR35092023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021656Orig1s023ltr.pdf 2/7/2013
AP08/25/2014SCM       
AP04/17/2015SCM       
AP09/20/2011SLR30073030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s030lbl.pdf 9/23/2011




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