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FDA Drug Application 017498 by PHARMACIA AND UPJOHN

Application Number017498
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/1/1984N       
AP01/15/1985SCS       
AP07/24/1985SCS       
AP03/18/1986SCM       
AP03/24/1986SLR       
AP04/7/1987SLR       
AP06/25/1987SLR       
AP03/2/1988SCS       
AP01/5/1988SLR       
AP04/27/1988SCM       
AP011/15/1991SCS       
AP012/14/1990SLR       
AP07/27/1992SLR       
AP01/21/1993SLR       
AP09/28/1995SCM       
AP09/28/1995SCP       
AP04/2/1997SLR       
AP04/2/1997SLR       
AP06/27/1997SCS       
AP010/28/1999SLR       
AP011/30/1999SCM       
AP010/27/2008SCP21096027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017498s027ltr.pdf 10/29/2008
AP010/27/2008SCP21137027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf 11/3/2008
AP08/27/2009SLR23370029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf 9/17/2009
AP08/27/2009SLR23960029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017498s029ltr.pdf 11/19/2009
AP02/1/2011SLR27706030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017498s030ltr.pdf 2/4/2011
AP02/1/2011SLR27726030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf 2/4/2011
AP010/15/2013SLR37428031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017498Orig1s031ltr.pdf 10/16/2013
AP010/15/2013SLR37508031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf 10/22/2013
AP05/22/2015SLR42897032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017498Orig1s032ltr.pdf 5/26/2015
AP05/22/2015SLR42903032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf 5/27/2015




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