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FDA Drug Application 021130 by PHARMACIA AND UPJOHN

Application Number021130
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
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
AP04/18/2000N1439000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf 4/18/2000
AP04/18/2000N1440000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf 4/18/2000
AP04/18/2000N2248000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm 4/18/2000
AP02/6/2001SLR       
AP012/19/2002SLR4973002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf 4/7/2003
AP012/19/2002SLR9683002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf 7/1/2004
AP012/19/2002SE511904003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm 6/27/2005
AP012/19/2002SE54978003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf 4/7/2003
AP012/19/2002SE59681003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf 7/1/2004
AP07/22/2003SE86182004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf 7/28/2003
AP01/5/2004SLR7523005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf 1/14/2004
AP06/23/2004SE59538006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf 6/25/2004
AP06/23/2004SE59553006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf 6/25/2004
AP02/10/2005SLR11110007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf 2/11/2005
AP05/12/2005SLR11615008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf 5/17/2005
AP05/12/2005SLR11643008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf 5/17/2005
AP05/12/2005SLR11644009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf 5/17/2005
AP05/12/2005SLR11616009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf 5/17/2005
AP011/2/2005SLR13040010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf 11/8/2005
AP04/26/2007SLR16346012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf 5/1/2007
AP04/26/2007SLR16374012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf 5/1/2007
AP04/26/2007SLR39772012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021130Orig1s012.pdf 7/7/2014
AP03/26/2007SCM       
AP03/21/2007SCS       
AP06/8/2007SCM       
AP06/20/2008SLR20083016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf 6/26/2008
AP06/20/2008SLR20061016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf 6/24/2008
AP06/20/2008SLR20062017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf 6/24/2008
AP09/18/2007SCM       
AP02/19/2008SCM       
AP012/8/2009SLR24280020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf 12/11/2009
AP012/8/2009SLR24628020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf 1/26/2010
AP07/16/2010SLR25978022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021130s022lbl.pdf 7/19/2010
AP07/16/2010SLR26005022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf 7/23/2010
AP05/3/2013SLR35977023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf 5/7/2013
AP05/3/2013SLR35996023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf 5/9/2013
AP05/3/2013SLR35997024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf 5/9/2013
AP05/3/2013SLR35978024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf 5/7/2013
AP02/13/2012SLR31789028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021130s028lbl.pdf 2/14/2012
AP02/13/2012SLR31794028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf 2/15/2012
AP01/24/2014SLR38369032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf 1/27/2014
AP01/24/2014SLR38374032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf 1/28/2014
AP07/28/2014SCM       
AP06/5/2015SLR43015035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf 6/10/2015
AP06/5/2015SLR43016035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf 6/10/2015




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