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FDA Drug Application 019011 by BRAINTREE

Application Number019011
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
AP07/13/1984N37319000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370635.pdf 10/3/2013
AP02/22/1985SLR       
AP04/19/1985SLR       
AP011/5/1986SLR       
AP06/2/1992SCP       
AP08/20/1992SLR       
AP09/17/1992SLR       
AP03/24/1993SLR       
AP03/24/1993SLR       
AP010/30/1995SCP       
AP011/4/1996SCM       
AP06/3/1997SCM       
AP03/25/1999SCF       
AP010/7/1999SCF       
AP02/23/2001SCM       
AP09/19/2002SLR2170015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19011slr015ltr.pdf 9/19/2002
AP09/23/2013SLR37196025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019011s025lbl.pdf 9/23/2013
AP09/23/2013SLR37209025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019011Orig1s025ltr.pdf 9/24/2013
AP06/5/2015SCM       
AP05/6/2016SCM       




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