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FDA Drug Application 022118 by SANTARUS INC

Application Number022118
Application Type New Drug Application
Sponsor ApplicantSANTARUS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/10/2007N17605000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022118s000ltr.pdf 8/14/2007
AP08/10/2007N17619000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022118lbl.pdf 8/14/2007
AP08/10/2007N21107000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022118_fenofibrate_toc.cfm 10/30/2008
AP02/29/2008SLR19366001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022118s001lbl.pdf 3/5/2008
AP02/29/2008SLR19384001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022118s001ltr.pdf 3/5/2008
AP03/5/2012SLR32104003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118s003ltr.pdf 3/14/2012
AP010/31/2012SLR34275005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118Orig1s005ltr.pdf 11/6/2012
AP010/31/2012SLR34317005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022118s005lbl.pdf 11/6/2012




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