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FDA Drug Application 125422 by THROMBOGENICS, INC

Application Number125422
Application Type Biologic License Application
Sponsor ApplicantTHROMBOGENICS, INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/17/2012N34125000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf 10/18/2012
AP010/17/2012N34520000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125422_jetrea_toc.cfm 12/4/2012
AP010/17/2012N34557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125422Orig1s000ltr.pdf 12/5/2012
AP06/13/2014SE839556025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf 6/17/2014
AP06/13/2014SE839575025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125422Orig1s025ltr.pdf 6/18/2014
AP03/27/2016S45527037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf 3/29/2016
AP03/27/2016S45532037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125422Orig1s037ltr.pdf 3/29/2016




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