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FDA Drug Application 021178 by BRISTOL MYERS SQUIBB

Application Number021178
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/31/2000N7456000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-178_Glucovance.cfm 12/31/2003
AP07/31/2000N1395000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21178ltr.pdf 7/31/2000
AP07/31/2000N1396000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21178lbl.pdf 7/31/2000
AP012/13/2000SCM       
AP02/28/2001SLR       
AP07/8/2002SCS       
AP09/30/2002SE12150004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21178se1-004ltr.pdf 9/30/2002
AP09/30/2002SE12151004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21178s4lbl.pdf 9/30/2002
AP09/30/2002SE16844004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-178S004_Glucovance.cfm 10/29/2003
AP07/2/2002SCE       
AP03/15/2004SE57993007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21178se5-007ltr.pdf 3/19/2004
AP03/15/2004SE58234007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21178se5-007_glucovance_lbl.pdf 4/5/2004
AP012/14/2006SLR15497009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021178s009lbl.pdf 12/26/2006
AP012/14/2006SLR15535009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021178s009ltr.pdf 12/28/2006
AP09/16/2008SLR20787010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021178s010ltr.pdf 9/17/2008
AP09/16/2008SLR20857010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021178s010lbl.pdf 9/19/2008
AP011/24/2009SLR24170011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021178s011lbl.pdf 12/2/2009
AP011/24/2010SLR27093012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021178s012ltr.pdf 11/30/2010
AP011/24/2010SLR27121012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021178s012lbl.pdf 12/1/2010
AP03/14/2013SCM       
AP08/15/2013SCM       
AP010/15/2013SLR37425015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021178Orig1s015ltr.pdf 10/16/2013
AP010/15/2013SLR37513015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021178s015lbl.pdf 10/22/2013




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