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FDA Drug Application 050441 by PHARMACIA AND UPJOHN

Application Number050441
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/1972N       
AP03/17/1997SLR       
AP03/17/1997SLR       
AP06/11/1991SLR       
AP03/23/1993SCS       
AP03/17/1997SLR       
AP03/5/1996SLR       
AP012/20/1995SLR       
AP02/21/1995SLR       
AP07/17/1997SLR       
AP012/12/1997SLR       
AP09/29/2004SLR10359045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf 10/4/2004
AP09/29/2004SLR10360045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf 10/4/2004
AP04/3/2000SCM       
AP011/21/2001SLR2483047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50441s47ltr.pdf 11/21/2001
AP011/21/2001SLR5561047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50441s47lbl.pdf 5/2/2003
AP01/28/2004SLR7633048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf 2/2/2004
AP02/21/2008SLR19279053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf 2/25/2008
AP02/21/2008SLR19287053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s053ltr.pdf 2/25/2008
AP04/14/2008SLR19653055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf 4/16/2008
AP04/14/2008SLR19717055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf 4/23/2008
AP010/15/2010SLR26707059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050441s059ltr.pdf 10/20/2010
AP06/7/2011SLR29089061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf 6/10/2011
AP012/18/2012SCM       
AP06/10/2014SLR39528066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf 6/12/2014
AP06/10/2014SLR39662066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf 6/25/2014
AP06/10/2014SLR39529067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf 6/12/2014
AP06/10/2014SLR39748067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf 6/25/2014
AP06/10/2014SLR39530068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf 6/12/2014
AP06/10/2014SLR39749068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf 6/25/2014
AP010/20/2014SCM       
AP03/24/2016SLR45515071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf 3/28/2016
AP03/24/2016SLR45523071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf 3/29/2016
AP08/5/2016SLR46739072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf 8/9/2016
AP08/5/2016SLR46752072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf 8/9/2016
AP08/5/2016SLR46742073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf 8/9/2016
AP08/5/2016SLR46751073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf 8/9/2016




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