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FDA Drug Application 050675 by PHARMACIA AND UPJOHN

Application Number050675
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/7/1992N       
AP010/12/1993SLR       
AP04/8/1993SLR       
AP06/16/1995SE4       
AP04/22/1993SLR       
AP010/20/1993SLR       
AP011/2/1993SLR       
AP07/6/1994SLR       
AP05/7/1996SE2       
AP03/14/1996SE1       
AP03/14/1996SLR       
AP09/28/1995SLR       
AP012/9/1996SCS       
AP03/19/1997SLR       
AP011/20/1998SE2709014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf 11/20/1998
AP011/20/1998SE22236014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675S14_Vantin.cfm 11/20/1998
AP011/20/1998SE14869015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050674s012.cfm 7/27/1999
AP011/20/1998SE1760015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf 11/20/1998
AP06/2/2004SLR9074016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf 6/7/2004
AP06/2/2004SLR9139016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf 6/7/2004
AP06/5/2007SLR16708017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050674s014, 050675s017ltr.pdf 6/7/2007
AP06/5/2007SLR16725017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf 6/7/2007
AP06/21/2013SLR36370018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675Orig1s018ltr.pdf 6/24/2013
AP06/21/2013SLR36375018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050674s015,050675s018lbl.pdf 6/25/2013




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