Back to FDA Applications sponsored by GENZYME CORP

FDA Drug Application 205494 by GENZYME CORP

Application Number205494
Application Type New Drug Application
Sponsor ApplicantGENZYME CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/19/2014N40265000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205494Orig1s000ltr.pdf 8/20/2014
AP08/19/2014N40301000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf 8/22/2014
AP08/19/2014N40501000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000TOC.cfm 9/17/2014
AP08/19/2014N40502000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205494Orig1s000SumR.pdf 9/17/2014
AP011/5/2014SCM       
AP05/11/2015SCM       




Back to FDA Applications sponsored by GENZYME CORP