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FDA Drug Application 018766 by PHARMACIA AND UPJOHN

Application Number018766
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
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
AP010/31/1988N24214000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085913.pdf 12/4/2009
AP05/5/1989SLR       
AP09/6/1989SCS       
AP09/4/1991SCS       
AP04/25/1994SCS       
AP03/25/1994SCP       
AP010/30/2001SLR       
AP010/30/2001SLR       
AP012/13/1999SCP       
AP01/24/2006SLR13493013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018766s013lbl.pdf 1/25/2006
AP01/24/2006SLR13530013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018766s013ltr.pdf 1/30/2006
AP06/21/2007SLR16905014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018766s014ltr.pdf 7/5/2007
AP08/13/2010SLR26298015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015lbl.pdf 8/28/2010
AP08/13/2010SLR26299015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf 8/28/2010
AP08/13/2010SLR26363015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018766s015ltr.pdf 9/7/2010
AP05/9/2016SLR45935020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018766Orig1s020ltr.pdf 5/11/2016
AP05/9/2016SLR45938020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018766s020lbl.pdf 5/11/2016




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