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FDA Drug Application 019953 by B BRAUN

Application Number019953
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
AP07/20/1992N       
AP03/29/1993SCP       
AP012/2/1992SCM       
AP012/22/1992SLR       
AP03/9/1995SCS       
AP07/30/1996SCM       
AP06/5/1998SCS       
AP03/1/2000SCS       
AP011/22/2000SCS       
AP02/15/2002SCP       
AP07/12/2002SCS       
AP04/13/2004SLR8387012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019953slr012ltr.pdf 4/20/2004
AP08/22/2014SCM       
AP02/26/2009SLR21928021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019953s021ltr.pdf 3/3/2009
AP02/26/2009SLR22033021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019953s021lbl.pdf 3/17/2009
AP012/27/2011SLR31260025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019953s025lbl.pdf 12/23/2011
AP012/27/2011SLR31298025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019953s025ltr.pdf 12/29/2011
AP01/10/2013SLR34878029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s029lbl.pdf 1/11/2013
AP01/10/2013SLR34879029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s029ltr.pdf 1/14/2013
AP08/30/2013SLR36938030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019953Orig1s030ltr.pdf 9/4/2013
AP08/30/2013SLR37016030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019953s030lbl.pdf 9/9/2013
AP05/12/2016SLR46033032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019953Orig1s032ltr.pdf 5/16/2016
AP05/12/2016SLR46040032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019953s032lbl.pdf 5/17/2016




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