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FDA Drug Application 050796 by B BRAUN

Application Number050796
Application Type New Drug Application
Sponsor ApplicantB BRAUN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/20/2005N11504000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050796ltr.pdf 4/28/2005
AP04/20/2005N11523000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf 4/28/2005
AP04/20/2005N16874000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050796s000TOC.cfm 7/2/2007
AP09/10/2007SLR17835004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050796s004lbl.pdf 9/11/2007
AP09/10/2007SLR17844004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050796s004ltr.pdf 9/11/2007
AP05/8/2008SLR21376007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf 12/19/2008
AP05/8/2008SLR21377008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf 12/19/2008
AP01/13/2012SLR31697011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050796s011ltr(2).pdf 2/7/2012
AP01/13/2012SLR31698011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050796Orig1s011lbledt.pdf 2/7/2012
AP06/25/2010SLR25867012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050796s012ltr.pdf 6/30/2010
AP06/25/2010SLR25890012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050796s012lbl.pdf 7/1/2010
AP03/11/2013SLR35413014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s014lbl.pdf 3/11/2013
AP03/11/2013SLR35442014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Origs014ltr.pdf 3/13/2013
AP04/10/2013SLR35695017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Orig1s017ltr.pdf 4/16/2013
AP04/10/2013SLR35721017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf 4/16/2013
AP02/7/2014SCM       
AP07/9/2015SLR43315019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050796s019lbl.pdf 7/10/2015
AP07/9/2015SLR43326019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050796Orig1s019ltr.pdf 7/13/2015
AP010/7/2016SCM       




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