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FDA Drug Application 021850 by SANTARUS

Application Number021850
Application Type New Drug Application
Sponsor ApplicantSANTARUS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/24/2006N13852000 4/5/2006
AP03/24/2006N15766000 2/5/2007
AP03/24/2006N31065000 12/20/2011
AP01/20/2010SLR24590002 1/24/2010
AP01/20/2010SLR24679002,021849s003,021850s002ltr.pdf 1/29/2010
AP09/3/2010SLR26425003,021849s004,021850s003,022456s002ltr.pdf 9/8/2010
AP09/3/2010SLR26467003,021849s004,021850s003,022456s002lbl.pdf 9/10/2010

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