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FDA Drug Application 019797 by BRAINTREE

Application Number019797
Application Type New Drug Application
Sponsor ApplicantBRAINTREE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/22/1991N37320000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf 10/3/2013
AP04/29/1993SCS       
AP011/18/1994SCF       
AP011/2/1995SCP       
AP011/4/1996SCM       
AP06/3/1997SCM       
AP012/10/1997SLR       
AP012/10/1997SLR       
AP03/25/1999SCF       
AP012/13/1999SCF       
AP01/28/2000SCF       
AP010/9/1999SCF       
AP02/23/2001SCM       
AP06/30/2003SCF9478013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19797scf013ltr.pdf 6/18/2004
AP08/7/2003SCM       
AP01/27/2010SLR       
AP09/23/2013SLR37197022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019797s022lbl.pdf 9/23/2013
AP09/23/2013SLR37212022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019797Orig1s022ltr.pdf 9/24/2013




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