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FDA Drug Application 009866 by PHARMACIA AND UPJOHN

Application Number009866
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
AP04/27/1955N       
AP06/18/1979SCE       
AP09/24/1979SCE       
AP04/14/1980SLR       
AP012/15/1981SCP       
AP012/15/1981SLR       
AP03/22/1989SLR       
AP07/24/1985SLR       
AP07/23/1987SCP       
AP07/2/1987SCP       
AP05/13/1988SCM       
AP03/29/1990SCS       
AP01/16/1990SCS       
AP04/1/1991SCS       
AP012/28/1993SLR       
AP012/6/1994SCS       
AP03/25/1994SCP       
AP09/15/1994SCS       
AP011/25/1999SCS       
AP04/4/2000SCM       
AP010/21/2002SCS       
AP09/1/2009SLR23528077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf 10/5/2009
AP09/1/2009SLR23749077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s79ltr.pdf 11/9/2009
AP09/1/2009SLR23529079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf 10/5/2009
AP09/1/2009SLR23750079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s079ltr.pdf 11/9/2009
AP06/16/2010SCM25824080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009866s080ltr.pdf 6/28/2010
AP06/16/2010SCM25887080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf 7/1/2010
AP09/23/2015SCM       
AP09/6/2014SCM       
AP04/4/2014SCM       
AP011/8/2013SCM       
AP09/27/2013SCM       
AP09/8/2016SLR47007098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf 9/9/2016
AP09/8/2016SLR47012098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf 9/9/2016
AP03/28/2014SCM       
AP07/22/2014SCM       
AP06/9/2014SCM       
AP06/24/2014SCM       
AP07/3/2014SLR39785104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009866Orig1s104ltr.pdf 7/8/2014
AP07/3/2014SLR39811104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf 7/8/2014
AP09/8/2016SLR47008105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf 9/9/2016
AP09/8/2016SLR47013105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf 9/9/2016
AP02/25/2016SCM       




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