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FDA Drug Application 021567 by BRISTOL MYERS SQUIBB

Application Number021567
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/20/2003N6070000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21567_reyataz_lbl.pdf 7/8/2003
AP06/20/2003N6401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21567ltr.pdf 8/6/2003
AP06/20/2003N6623000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021567_reyataz_toc.cfm 9/9/2003
AP03/16/2004SLR7989001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567slr001ltr.pdf 3/19/2004
AP03/16/2004SLR8224001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567slr001_reyataz_lbl.pdf 4/5/2004
AP07/6/2004SE29719002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567se2-002_reyataz_lbl.pdf 7/7/2004
AP07/6/2004SE29720002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567se2-002ltr.pdf 7/7/2004
AP010/5/2004SLR10381004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567s004ltr.pdf 10/8/2004
AP010/5/2004SLR10402004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567s004lbl.pdf 10/8/2004
AP07/18/2005SLR12032005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021567s005ltr.pdf 7/21/2005
AP07/18/2005SLR12041005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021567s005lbl.pdf 7/21/2005
AP01/25/2006SLR13477007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s007lbl.pdf 1/25/2006
AP01/25/2006SLR13554007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s007ltr.pdf 1/30/2006
AP08/9/2006SLR14664008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf 8/11/2006
AP08/9/2006SLR14699008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf 8/14/2006
AP010/16/2006SCF15126009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s009lbl.pdf 10/18/2006
AP010/16/2006SCF15192009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s009ltr.pdf 10/23/2006
AP08/9/2006SLR14665011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf 8/11/2006
AP08/9/2006SLR14700011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf 8/14/2006
AP03/22/2007SLR16120012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s012LTR.pdf 3/31/2007
AP03/22/2007SLR16134012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s012lbl.pdf 3/31/2007
AP012/21/2007SLR18723014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s014lbl.pdf 1/8/2008
AP012/21/2007SLR18758014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s014ltr.pdf 1/9/2008
AP03/25/2008SE519541015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s015lbl.pdf 3/27/2008
AP03/25/2008SE519550015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s015ltr.pdf 3/28/2008
AP08/15/2008SLR20651016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s016ltr.pdf 8/20/2008
AP08/15/2008SLR20681016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s016lbl.pdf 8/26/2008
AP09/30/2008SE520917017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s017ltr.pdf 10/2/2008
AP09/30/2008SE520941017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s017lbl.pdf 10/3/2008
AP02/20/2008SLR19258018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s018ltr.pdf 2/22/2008
AP02/20/2008SLR19272018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s018lbl.pdf 2/25/2008
AP011/5/2009SE824093019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021567s019lbl.pdf 11/23/2009
AP011/5/2009SE824606019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021567s019ltr.pdf 1/25/2010
AP011/5/2009SE840134019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021567Orig1s019.pdf 8/5/2014
AP01/22/2010SLR24599022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s022lbl.pdf 1/24/2010
AP01/22/2010SLR24657022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s022ltr.pdf 1/28/2010
AP04/26/2010SLR25384023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s023ltr.pdf 4/29/2010
AP04/26/2010SLR25410023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s023lbl.pdf 5/3/2010
AP02/4/2011SE527786025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s025lbl.pdf 2/9/2011
AP02/4/2011SE527805025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s025ltr.pdf 2/10/2011
AP02/4/2011SE543419025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021567Orig1s025.pdf 7/20/2015
AP010/17/2011SE230342026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s026lbl.pdf 10/17/2011
AP010/17/2011SE230345026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s026ltr.pdf 10/19/2011
AP02/17/2012SLR31872027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s027ltr.pdf 2/23/2012
AP02/17/2012SLR31885027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s027lbl.pdf 2/24/2012
AP03/14/2012SLR32133028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s028ltr.pdf 3/16/2012
AP03/14/2012SLR32141028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s028lbl.pdf 3/16/2012
AP01/30/2013SLR35047031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s031ltr.pdf 2/4/2013
AP08/15/2013SLR36837032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf 8/20/2013
AP08/15/2013SLR36859032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf 8/21/2013
AP08/15/2013SLR36838033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf 8/20/2013
AP08/15/2013SLR36860033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf 8/21/2013
AP02/26/2014SCM       
AP06/2/2014SE839431035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567Orig1s035ltr.pdf 6/3/2014
AP06/2/2014SE839432035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf 6/3/2014
AP06/2/2014SE842443035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035TOC.cfm 4/7/2015
AP06/2/2014SE842444035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035SumR.pdf 4/7/2015
AP02/26/2015SLR41947036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s036ltr.pdf 2/27/2015
AP12/26/2015SLR41947036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s036ltr.pdf 2/27/2015
AP03/27/2015SLR42349037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352Orig1s002ltr.pdf 4/1/2015
AP03/27/2015SLR42402037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf 4/2/2015
AP09/24/2015SE844013038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567Orig1s038ltr.pdf 9/28/2015
AP09/24/2015SE844733038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf 12/10/2015
AP09/15/2016SLR47089039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021567Orig1s039,206352Orig1s004ltr.pdf 9/20/2016
AP09/15/2016SLR47108039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf 9/20/2016




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