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FDA Drug Application 021131 by PHARMACIA AND UPJOHN

Application Number021131
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/18/2000N2249000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf 4/18/2000
AP04/18/2000N2250000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf 4/18/2000
AP04/18/2000N2251000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm 4/18/2000
AP02/6/2001SLR       
AP012/19/2002SLR4974002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf 4/7/2003
AP012/19/2002SLR9684002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf 7/1/2004
AP012/19/2002SE511974003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm 7/11/2005
AP012/19/2002SE54977003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf 4/7/2003
AP012/19/2002SE59682003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf 7/1/2004
AP07/22/2003SE86183004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf 7/28/2003
AP01/5/2004SLR7524006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf 1/14/2004
AP06/23/2004SE59539007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf 6/25/2004
AP06/23/2004SE59554007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf 6/25/2004
AP02/10/2005SLR11111008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf 2/11/2005
AP05/12/2005SLR11617009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf 5/17/2005
AP05/12/2005SLR11645009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf 5/17/2005
AP05/12/2005SLR11646010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf 5/17/2005
AP05/12/2005SLR11618010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf 5/17/2005
AP011/2/2005SLR13041011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf 11/8/2005
AP04/26/2007SLR16345012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf 5/1/2007
AP04/26/2007SLR16373012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf 5/1/2007
AP04/26/2007SLR39773012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021131Orig1s012.pdf 7/7/2014
AP06/20/2008SLR20082013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf 6/26/2008
AP06/20/2008SLR20063013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf 6/24/2008
AP06/20/2008SLR20064014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf 6/24/2008
AP08/2/2007SCS       
AP09/18/2007SCM       
AP012/8/2009SLR24281017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf 12/11/2009
AP012/8/2009SLR24629017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf 1/26/2010
AP07/16/2010SLR25979020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021131s020lbl.pdf 7/16/2010
AP07/16/2010SLR26007020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf 7/23/2010
AP05/3/2013SLR35979021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf 5/7/2013
AP05/3/2013SLR35994021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf 5/9/2013
AP05/3/2013SLR35995022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf 5/9/2013
AP05/3/2013SLR35980022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf 5/7/2013
AP02/13/2012SLR31787024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021131s024lbl.pdf 2/14/2012
AP02/13/2012SLR31795024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf 2/15/2012
AP01/24/2014SLR38370026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf 1/27/2014
AP01/24/2014SLR38375026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf 1/28/2014
AP07/28/2014SCM       
AP06/5/2015SLR43014029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf 6/10/2015
AP06/5/2015SLR43017029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf 6/10/2015




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