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FDA Drug Application 050689 by PHARMACIA AND UPJOHN

Application Number050689
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority*
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1992N       
AP07/26/1993SLR       
AP07/28/1993SCM       
AP06/22/1993SCS       
AP09/8/1995SCE       
AP05/31/1994SCS       
AP06/6/1994SCS       
AP01/11/1996SCP       
AP011/3/1995SLR       
AP09/13/1996SCM       
AP011/9/2001SLR3656011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf 11/9/2001
AP011/9/2001SLR5591011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50689s11s13lbl.pdf 5/7/2003
AP01/15/1999SCM       
AP011/9/2001SLR3657013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf 11/9/2001
AP01/29/2001SCS       
AP05/14/2008SLR19833016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050689s016ltr.pdf 5/14/2008
AP05/14/2008SLR19943016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050689s016lbl.pdf 6/5/2008
AP011/13/2014SLR40992018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050689Orig1s018ltr.pdf 11/14/2014
AP011/13/2014SLR41127018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050689Orig1s018lbl.pdf 12/2/2014
AP07/1/2015SLR43254022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050689s022lbl.pdf 7/6/2015
AP07/1/2015SLR43281022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050689Orig1s022ltr.pdf 7/9/2015




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