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FDA Drug Application 019422 by XTTRIUM

Application Number019422
Application Type New Drug Application
Sponsor ApplicantXTTRIUM
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
AP012/17/1985N       
AP012/27/1989SE1       
AP03/2/1988SCP       
AP09/16/1987SCP       
AP09/16/1987SCM       
AP04/12/1988SCE       
AP06/28/1988SCS       
AP08/12/1988SCM       
AP07/28/1989SCM       
AP011/6/1992SCP       
AP05/10/1995SCP       
AP05/10/1995SCM       
AP02/6/1996SCS       
AP02/6/1996SCS       
AP02/12/1996SCF       
AP04/3/1996SCS       
AP05/6/1996SCP       
AP03/11/1997SCE       
AP04/17/1997SCP       
AP01/8/1998SCS       
AP09/30/1998SCP       
AP010/19/1998SCS       
AP03/29/2000SCP       
AP010/8/1999SCP       
AP012/19/2003SE87345032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19422se8-032ltr.pdf 12/23/2003
AP012/19/2003SE817251032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019422_S032_ChlorhexidineTOC.cfm 7/9/2007
AP012/20/2004SCP10883033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019422s033ltr.pdf 12/30/2004
AP02/25/2009SCP21917036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s036ltr.pdf 2/27/2009
AP02/25/2009SCP21916037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s037ltr.pdf 2/27/2009
AP012/12/2012SLR34681043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019422Orig1s043ltr.pdf 12/18/2012
AP012/12/2012SLR38275043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf 1/14/2014
AP03/24/2016SCM       
AP04/11/2016SCM       




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