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FDA Drug Application 021460 by BRISTOL MYERS SQUIBB

Application Number021460
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/21/2002N3557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21460ltr.pdf 10/21/2002
AP010/21/2002N3558000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21460lbl.pdf 10/21/2002
AP010/21/2002N5529000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021460_metaglip.cfm 4/30/2003
AP06/18/2007SLR16833005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021460s005lbl.pdf 6/27/2007
AP06/18/2007SLR16915005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021460s005ltr.pdf 7/5/2007
AP08/18/2008SLR20650007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021460s007ltr.pdf 8/20/2008
AP08/18/2008SLR20680007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021460s007lbl.pdf 8/26/2008
AP08/7/2009SLR23406008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021460s008lbl.pdf 9/18/2009
AP08/7/2009SLR24132008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021460s008ltr.pdf 11/25/2009
AP02/1/2011SLR27699009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021460s009ltr.pdf 2/3/2011
AP02/1/2011SLR27725009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021460s009lbl.pdf 2/4/2011
AP010/15/2013SLR37424010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021460Orig1s010ltr.pdf 10/16/2013
AP010/15/2013SLR37512010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021460s010lbl.pdf 10/22/2013




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