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FDA Drug Application 019125 by XTTRIUM

Application Number019125
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
AP012/24/1984N       
AP06/9/1986SCM       
AP09/4/1985SCM       
AP012/27/1989SE1       
AP08/25/1988SCE       
AP08/14/1989SCF       
AP01/23/1990SCM       
AP03/7/1991SCM       
AP011/6/1992SCP       
AP05/10/1995SCP       
AP05/10/1995SCM       
AP08/28/1995SCF       
AP02/6/1996SCS       
AP02/6/1996SCS       
AP02/21/1996SCF       
AP04/12/1996SCS       
AP05/6/1996SCP       
AP06/6/1996SCS6634028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-125S028.pdf 9/11/2003
AP09/11/1998SCS       
AP09/8/1999SCS       
AP010/8/1999SCP       
AP05/16/2005SLR11658034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019125s034ltr.pdf 5/18/2005
AP011/9/2012SLR34366040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019125Orig1s040ltr.pdf 11/13/2012
AP010/17/2014SLR40857042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019125Orig1s042ltr.pdf 10/22/2014
AP010/17/2014SLR40903042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.pdf 10/30/2014




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