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FDA Drug Application 021489 by BRACCO

Application Number021489
Application Type New Drug Application
Sponsor ApplicantBRACCO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/9/2003N6795000 10/16/2003
AP010/9/2003N6796000 10/16/2003
AP010/9/2003N14266000 6/9/2006
AP010/9/2003N14531000 7/25/2006
AP09/4/2007SLR17753001,021489s001lbl.pdf 9/6/2007
AP09/4/2007SLR17768001, 021489s001ltr.pdf 9/6/2007
AP012/20/2010SLR27321002 12/20/2010
AP012/20/2010SLR27334002,021489s002ltr.pdf 12/22/2010
AP08/13/2013SLR36806003,021489s003lbl.pdf 8/15/2013
AP08/13/2013SLR36812003,021489Orig1s003ltr.pdf 8/16/2013
AP07/22/2014SLR39970004 7/24/2014
AP07/22/2014SLR39993004 7/24/2014

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