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FDA Drug Application 125141 by GENZYME

Application Number125141
Application Type Biologic License Application
Sponsor ApplicantGENZYME
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
AP04/28/2006N139940000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf 4/28/2006
AP04/28/2006N140370000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125141s0_LTR.pdf 5/2/2006
AP04/28/2006N143480000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125141s000_MyozymeTOC.cfm 6/21/2006
AP07/9/2012S331720176   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125141Orig1s0176ltr.pdf 7/13/2012
AP07/9/2012S331790176   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf 7/13/2012
AP012/8/2008SLR21404074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125141s074ltr.pdf 12/24/2008
AP012/8/2008SLR21659074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf 1/16/2009
AP05/20/2014SLR39338219   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125141Orig1s219ltr.pdf 5/22/2014
AP05/20/2014SLR39395219   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf 5/28/2014




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