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FDA Drug Application 011856 by PHARMACIA AND UPJOHN

Application Number011856
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/1959N       
AP011/13/1979SLR       
AP08/11/1981SCP       
AP04/28/1980SCP       
AP09/30/1980SCP       
AP010/16/1981SCP       
AP02/20/1981SLR       
AP02/27/1985SCS       
AP05/3/1983SLR       
AP03/22/1989SLR       
AP03/28/1985SCS       
AP012/8/1986SCS       
AP02/14/1986SCP       
AP01/31/1986SCE       
AP01/23/1986SCS       
AP012/8/1986SCP       
AP010/2/1989SCP       
AP07/11/1989SCP       
AP04/24/1990SCS       
AP04/22/1994SCS       
AP012/7/1990SCS       
AP09/4/1991SLR       
AP011/5/1993SCS       
AP03/25/1994SCP       
AP04/6/1994SCP       
AP09/15/1994SCS       
AP02/26/1998SCS       
AP03/16/1999SCS       
AP04/3/2000SCM       
AP010/21/2002SCS       
AP010/20/2011SCM30400103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf 10/25/2011
AP010/20/2011SCM30416103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf 10/25/2011
AP010/20/2011SLR30401104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf 10/25/2011
AP010/20/2011SLR30417104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf 10/25/2011
AP06/24/2010SLR25825107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/011856s107ltr.pdf 6/28/2010
AP06/24/2010SLR25888107   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf 7/1/2010
AP04/4/2014SCM       
AP03/28/2014SCM       
AP07/22/2014SCM       
AP06/9/2014SCM       
AP07/3/2014SLR39778123   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011856Orig1s123ltr.pdf 7/7/2014
AP07/3/2014SLR39818123   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf 7/9/2014
AP09/8/2016SLR47002124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf 9/9/2016
AP09/8/2016SLR47015124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf 9/9/2016
AP09/8/2016SLR47003126   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf 9/9/2016
AP09/8/2016SLR47016126   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf 9/9/2016
AP08/6/2015SCM       




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