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FDA Drug Application 050671 by BAXTER HLTHCARE

Application Number050671
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP04/29/1993N       
AP07/30/1996SCS       
AP01/8/1998SE5447002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf 1/8/1998
AP011/7/1997SCM       
AP01/8/1998SLR426004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050671s002_vancocin.pdf 1/8/1998
AP03/1/1999SCS       
AP03/30/2004SLR8209006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50671slr006_vancocin_lbl.pdf 4/5/2004
AP03/30/2004SLR8294006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50671slr006ltr.pdf 4/7/2004
AP09/17/2007SLR17889010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050671s010lbl.pdf 9/19/2007
AP09/17/2007SLR17989010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050671s010ltr.pdf 9/25/2007
AP05/2/2008SLR19781012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050671s012ltr.pdf 5/7/2008
AP05/2/2008SLR19783012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050671s012lbl.pdf 5/8/2008
AP03/11/2009SLR21999014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050671s014ltr.pdf 3/13/2009
AP03/11/2009SLR22190014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050671s014lbl.pdf 4/3/2009
AP01/17/2012SLR31412018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050671s018ltr.pdf 1/19/2012
AP01/17/2012SLR31473018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050671s018lbl.pdf 1/23/2012
AP011/13/2015SCM       
AP012/18/2015SCM44840022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050671Orig1s022ltr.pdf 12/22/2015
AP012/18/2015SCM44878022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050671s022lbl.pdf 12/28/2015




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