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FDA Drug Application 203595 by BRAINTREE LABS

Application Number203595
Application Type New Drug Application
Sponsor ApplicantBRAINTREE LABS
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
AP01/18/2013N34932000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203595Orig1s000ltr.pdf 1/23/2013
AP01/18/2013N34934000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203595s000lbl.pdf 1/23/2013
AP01/18/2013N35073000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337734.pdf 2/5/2013
AP01/18/2013N38362000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203595Orig1s000TOC.cfm 1/24/2014
AP01/18/2013N38363000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203595Orig1s000SumR.pdf 1/24/2014
AP08/15/2013SCM       
AP08/15/2013SCM       




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