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FDA Drug Application 125277 by DYAX CORP.

Application Number125277
Application Type Biologic License Application
Sponsor ApplicantDYAX CORP.
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
AP011/27/2009N24175000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277lbl.pdf 12/2/2009
AP011/27/2009N24177000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277MedGuide.pdf 12/2/2009
AP011/27/2009N24222000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125277s000ltr.pdf 12/8/2009
AP011/27/2009N24747000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000TOC.cfm 2/14/2010
AP011/27/2009N24752000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000SumR.pdf 2/14/2010
AP011/27/2009N29461000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM261985.pdf 7/8/2011
AP04/24/2012S325450050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125277s0050ltr.pdf 4/27/2012
AP04/5/2011S28842032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s032ltr.pdf 5/17/2011
AP08/17/2011S29984037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125277s037ltr.pdf 9/13/2011
AP04/10/2013SLR35685065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125277Orig1s065ltr.pdf 4/16/2013
AP03/28/2014SE838934070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s070lbl.pdf 4/1/2014
AP03/28/2014SE838951070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s70ltr.pdf 4/2/2014
AP09/8/2014SLR40457071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf 9/9/2014
AP09/8/2014SLR40470071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125277Orig1s071ltr.pdf 9/10/2014




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