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FDA Drug Application 011757 by PHARMACIA AND UPJOHN

Application Number011757
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
AP05/27/1959N       
AP02/17/1981SCS       
AP07/12/1978SLR       
AP05/12/1986SLR       
AP07/29/1980SCE       
AP05/12/1986SLR       
AP03/9/1983SLR       
AP03/9/1983SLR       
AP01/5/1989SCP       
AP05/12/1986SLR       
AP012/14/1989SLR       
AP011/15/1990SCF       
AP012/28/1993SCP       
AP01/7/1994SCM       
AP01/24/1995SCP       
AP04/4/2000SCM       
AP05/22/2002SCS       
AP04/7/2009SLR22266085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf 4/16/2009
AP04/7/2009SLR22280085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf 4/16/2009
AP04/7/2009SLR22267086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf 4/16/2009
AP04/7/2009SLR22281086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf 4/16/2009
AP010/7/2013SCM       
AP010/11/2013SCM       
AP06/9/2014SCM       
AP07/3/2014SLR39794103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011757Orig1s103ltr.pdf 7/8/2014
AP07/3/2014SLR39822103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf 7/9/2014
AP09/8/2016SLR47004104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011757Orig1s104ltr.pdf 9/9/2016
AP09/8/2016SLR47014104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf 9/9/2016




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