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FDA Drug Application 021097 by SALIX PHARMS

Application Number021097
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/21/2000N15084000 10/11/2006
AP09/21/2000N1214000 9/21/2000
AP09/21/2000N1215000 9/21/2000
AP09/21/2000N2802000 9/21/2000
AP09/21/2000N35478000 3/19/2013
AP03/12/2002SCF2801005 3/12/2002
AP02/10/2005SLR11114007,009ltr.pdf 2/11/2005
AP02/10/2005SCP11113009,009ltr.pdf 2/11/2005
AP03/31/2006SLR13886010 4/7/2006
AP03/31/2006SLR14038010 5/2/2006
AP03/25/2009SLR22117013 3/26/2009
AP03/25/2009SLR22130013,021892s003ltr.pdf 3/27/2009
AP010/13/2009SLR23575014 10/14/2009
AP010/13/2009SLR23576014,021892s004lbl.pdf 10/14/2009
AP010/13/2009SLR24145014,021892s004ltr.pdf 11/25/2009
AP010/13/2009SLR30820014 10/10/2011
AP012/9/2011SLR30963015,021097s015ltr.pdf 12/14/2011
AP03/7/2013SLR35373016 3/8/2013
AP03/7/2013SLR35378016 3/8/2013

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