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FDA Drug Application 021748 by SANTARUS INC

Application Number021748
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
AP06/3/2005N11754000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021748ltr.pdf 6/7/2005
AP06/3/2005N11764000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf 6/7/2005
AP06/3/2005N14797000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021748s000_GlumetzaTOC.cfm 9/7/2006
AP011/1/2006SLR15297002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf 11/6/2006
AP011/1/2006SLR15310002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021748s002ltr.pdf 11/6/2006
AP012/4/2007SCF       
AP06/16/2009SLR22795005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf 6/22/2009
AP06/16/2009SLR22804005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021748s005ltr.pdf 6/23/2009
AP02/25/2010SLR24918008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021748s008ltr.pdf 3/3/2010
AP04/13/2011SLR28550010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf 4/15/2011
AP04/13/2011SLR28578010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021748s010ltr.pdf 4/19/2011
AP010/27/2015SCM       




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