Back to FDA Applications sponsored by PHARMACIA AND UPJOHN

FDA Drug Application 050674 by PHARMACIA AND UPJOHN

Application Number050674
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
AP08/7/1992N       
AP05/28/1993SE1       
AP04/8/1993SLR       
AP011/2/1993SLR       
AP07/6/1994SLR       
AP05/7/1996SE2       
AP03/14/1996SE1       
AP03/14/1996SLR       
AP09/28/1995SLR       
AP02/7/1996SLR       
AP011/20/1998SE1758012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50674s12ltr.pdf 11/20/1998
AP011/20/1998SE1759012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050674s012.cfm 11/20/1998
AP06/2/2004SLR9094013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf 6/7/2004
AP06/2/2004SLR9140013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf 6/7/2004
AP06/5/2007SLR16707014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050674s014, 050675s017ltr.pdf 6/7/2007
AP06/5/2007SLR16726014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf 6/7/2007
AP06/21/2013SLR36369015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675Orig1s018ltr.pdf 6/24/2013
AP06/21/2013SLR36376015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050674s015,050675s018lbl.pdf 6/25/2013




Back to FDA Applications sponsored by PHARMACIA AND UPJOHN

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.