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FDA Drug Application 050781 by ORAPHARMA

Application Number050781
Application Type New Drug Application
Sponsor ApplicantORAPHARMA
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
AP02/16/2001N4223000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50781_Arestin.cfm 3/7/2003
AP02/16/2001N5571000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50781lbl.pdf 5/2/2003
AP07/13/2001SCS       
AP08/14/2001SCS       
AP08/14/2001SCS       
AP09/14/2001SCS       
AP010/12/2001SCS       
AP01/28/2002SCS       
AP02/15/2008SLR19240012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050781s012ltr.pdf 2/20/2008
AP02/15/2008SLR19282012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050781s012lbl.pdf 2/25/2008
AP07/27/2012SLR33318019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050781Orig1s019ltr.pdf 7/31/2012
AP07/27/2012SLR33325019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050781s019lbl.pdf 7/31/2012




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