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FDA Drug Application 022372 by BRAINTREE LABS

Application Number022372
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
AP08/5/2010N26162000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022372s000ltr.pdf 8/10/2010
AP08/5/2010N26177000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000lbl.pdf 8/10/2010
AP08/5/2010N26178000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000MedGuide.pdf 8/10/2010
AP08/5/2010N30001000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372_suprep_toc.cfm 9/16/2011
AP08/5/2010N30002000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372Orig1s000SumR.pdf 9/16/2011
AP07/6/2011SLR29471003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022372s003ltr.pdf 7/12/2011
AP011/1/2012SLR34217004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf 11/2/2012
AP011/1/2012SLR34281004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022372Orig1s004ltr.pdf 11/6/2012
AP07/24/2012SCM       




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