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FDA Drug Application 021132 by PHARMACIA AND UPJOHN

Application Number021132
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
AP04/18/2000N2252000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf 4/18/2000
AP04/18/2000N2253000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf 4/18/2000
AP04/18/2000N2254000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm 4/18/2000
AP02/6/2001SLR       
AP012/19/2002SLR4975002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf 4/7/2003
AP012/19/2002SLR9685002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf 7/1/2004
AP012/19/2002SE54976003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf 4/7/2003
AP012/19/2002SE59680003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf 7/1/2004
AP012/19/2002SE511975003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm 7/11/2005
AP07/22/2003SE86184004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf 7/28/2003
AP01/5/2004SLR7525005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf 1/14/2004
AP06/23/2004SE59540006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf 6/25/2004
AP06/23/2004SE59555006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf 6/25/2004
AP02/10/2005SLR11112007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf 2/11/2005
AP05/12/2005SLR11619008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf 5/17/2005
AP05/12/2005SLR11647008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf 5/17/2005
AP05/12/2005SLR11620009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf 5/17/2005
AP05/12/2005SLR11648009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf 5/17/2005
AP011/2/2005SLR13042010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf 11/8/2005
AP04/26/2007SLR16344012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf 5/1/2007
AP04/26/2007SLR16372012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf 5/1/2007
AP04/26/2007SLR39774012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021132Orig1s012.pdf 7/7/2014
AP03/26/2007SCM       
AP06/20/2008SLR20065014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf 6/24/2008
AP06/20/2008SLR20081014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf 6/26/2008
AP06/20/2008SLR20066015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013, s014,021132s014,s015ltr.pdf 6/24/2008
AP09/18/2007SCM       
AP012/8/2009SLR24282018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf 12/11/2009
AP012/8/2009SLR24630018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf 1/26/2010
AP07/16/2010SLR25980021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021132s021lbl.pdf 7/19/2010
AP07/16/2010SLR26006021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf 7/23/2010
AP05/3/2013SLR35981022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf 5/7/2013
AP05/3/2013SLR35992022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf 5/9/2013
AP05/3/2013SLR35982023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf 5/7/2013
AP05/3/2013SLR35993023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf 5/9/2013
AP02/13/2012SLR31786027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021132s027lbl.pdf 2/14/2012
AP02/13/2012SLR31796027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf 2/15/2012
AP010/9/2013SCM       
AP01/24/2014SLR38371031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf 1/27/2014
AP01/24/2014SLR38376031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf 1/28/2014
AP07/28/2014SCM       
AP06/5/2015SLR43013034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf 6/10/2015
AP06/5/2015SLR43018034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf 6/10/2015




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