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FDA Drug Application 021357 by BRACCO

Application Number021357
Application Type New Drug Application
Sponsor ApplicantBRACCO
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
AP011/23/2004N10670000,21358ltr.pdf 12/2/2004
AP011/23/2004N10719000 12/3/2004
AP011/23/2004N11289000 3/28/2005
AP011/23/2004N14261000 6/9/2006
AP09/4/2007SLR17756003,021358s003lbl.pdf 9/6/2007
AP09/4/2007SLR17773003, 021358s003ltr.pdf 9/6/2007
AP010/2/2009SLR23566004 10/14/2009
AP010/2/2009SLR23785004 11/10/2009
AP03/17/2010SE525073006 3/18/2010
AP03/17/2010SE525087006 3/22/2010
AP012/20/2010SLR27314009 12/20/2010
AP012/20/2010SLR27332009 12/22/2010
AP07/6/2012SE133097011,021358s009ltr.pdf 7/9/2012
AP07/6/2012SE133102011 7/10/2012
AP07/30/2013SLR36675013,021358Orig1s012ltr.pdf 8/1/2013
AP07/30/2013SLR36754013,021358s012lbl.pdf 8/9/2013

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