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FDA Drug Application 021583 by PHARMACIA AND UPJOHN

Application Number021583
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/17/2004N10881000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021583ltr.pdf 12/30/2004
AP012/17/2004N10903000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf 12/30/2004
AP012/17/2004N16459000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021583s000TOC.cfm 5/9/2007
AP05/2/2005SLR11584001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s001ltr.pdf 5/4/2005
AP011/8/2005SLR13051003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf 11/16/2005
AP011/8/2005SLR13087003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s003ltr.pdf 11/18/2005
AP010/5/2007SLR18191006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021583s006ltr.pdf 10/10/2007
AP010/5/2007SLR18219006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf 10/10/2007
AP07/15/2009SCS22974011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf 7/16/2009
AP07/15/2009SCS22988011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021583s011ltr.pdf 7/17/2009
AP02/29/2016SCM       
AP08/4/2016SCM       
AP01/30/2015SLR41756025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021583Orig1s025ltr.pdf 2/2/2015
AP01/30/2015SLR41770025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf 2/3/2015
AP01/23/2015SLR41683026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf 1/26/2015
AP01/23/2015SLR41731026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf 1/29/2015
AP010/14/2016SLR47378032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf 10/17/2016
AP010/14/2016SLR47386032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s032ltr.pdf 10/19/2016




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