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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   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021850s000ltr.pdf 4/5/2006
AP03/24/2006N15766000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021850s000TOC.cfm 2/5/2007
AP03/24/2006N31065000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP01/20/2010SLR24590002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021850s002lbl.pdf 1/24/2010
AP01/20/2010SLR24679002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf 1/29/2010
AP09/3/2010SLR26425003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf 9/8/2010
AP09/3/2010SLR26467003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf 9/10/2010




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