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FDA Drug Application 050639 by PHARMACIA AND UPJOHN

Application Number050639
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
AP08/30/1989N       
AP04/18/1991SCG       
AP06/11/1991SLR       
AP04/10/1991SCG       
AP05/21/1992SCS       
AP03/17/1997SLR       
AP012/20/1995SLR       
AP04/5/1993SCS       
AP02/21/1995SLR       
AP03/9/1998SCM       
AP07/17/1997SLR       
AP012/12/1997SLR       
AP09/29/2004SLR10361013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf 10/4/2004
AP09/29/2004SLR10362013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf 10/4/2004
AP01/28/2004SLR7634014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf 2/2/2004
AP02/21/2008SLR19278015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf 2/25/2008
AP02/21/2008SLR19290015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050639s015ltr.pdf 2/25/2008
AP04/14/2008SLR19654016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf 4/16/2008
AP04/14/2008SLR19716016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf 4/23/2008
AP06/7/2011SLR29090022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf 6/10/2011
AP06/26/2013SCM       
AP010/9/2013SCM       
AP06/25/2014SLR39673027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf 6/27/2014
AP06/25/2014SLR39751027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf 7/3/2014
AP06/25/2014SLR39752028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf 7/3/2014
AP06/25/2014SLR39674028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf 6/27/2014
AP06/25/2014SLR39675029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf 6/27/2014
AP06/25/2014SLR39753029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf 7/3/2014
AP09/18/2014SCM       
AP03/24/2016SLR45516031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf 3/28/2016
AP03/24/2016SLR45524031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf 3/29/2016
AP05/20/2016SCM       
AP08/5/2016SLR46740033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf 8/9/2016
AP08/5/2016SLR46753033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf 8/9/2016
AP08/5/2016SLR46754034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf 8/9/2016
AP08/5/2016SLR46741034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf 8/9/2016




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