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FDA Drug Application 125327 by BTG INTERNATIONAL INC

Application Number125327
Application Type Biologic License Application
Sponsor ApplicantBTG INTERNATIONAL INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/17/2012N31391000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125327lbl.pdf 1/17/2012
AP01/17/2012N31417000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125327s000ltr.pdf 1/20/2012
AP01/17/2012N32060000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125327Orig1s000TOC.cfm 3/7/2012
AP03/29/2013SLR35589020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125327Orig1s020ltr.pdf 4/1/2013
AP03/29/2013SLR35623020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125327s020lbl.pdf 4/1/2013




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