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FDA Drug Application 103979 by GENZYME

Application Number103979
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
AP04/24/2003N79300000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm128159.htm 3/15/2004
AP04/24/2003N79310000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf 3/15/2004
AP04/24/2003N79320000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080585.htm 3/15/2004
AP04/24/2003N112080000Package Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103979_0000lbl.pdf 3/3/2005
AP010/13/2006S156295058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf 1/8/2007
AP010/13/2006S156325058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf 1/8/2007
AP010/13/2006S156335065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf 1/8/2007
AP010/13/2006S156305065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf 1/8/2007
AP010/13/2006S156315066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf 1/8/2007
AP010/13/2006S156345066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf 1/8/2007
AP012/17/2008SLR214225107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103979s5107ltr.pdf 12/29/2008
AP012/17/2008SLR216605107   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf 1/16/2009
AP05/14/2010S274605135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf 1/5/2011




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