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FDA Drug Application 103948 by GENZYME

Application Number103948
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
AP05/7/2001N127600000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103948s000_CampathTOC.cfm 9/13/2005
AP05/7/2001N131830000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm082681.htm 11/30/2005
AP05/7/2001N79180000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm 3/12/2004
AP05/7/2001N79190000   http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm088606.pdf 3/12/2004
AP05/7/2001N432060000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=340 7/2/2015
AP05/19/2004S91905035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103948-5035ltr.pdf 5/19/2004
AP05/19/2004S91945036   http://www.accessdata.fda.gov/drugsatfda_docs/label/biologics/103948-5036_campath_lbl.pdf 5/19/2004
AP05/19/2004S91895036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103948-5036ltr.pdf 5/19/2004
AP012/19/2006S156285065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103948s5065ltr.pdf 1/8/2007
AP012/19/2006S156365065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103948s5065lbl.pdf 1/8/2007
AP09/19/2007S180075070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103948s5070lt.pdf 9/25/2007
AP09/19/2007S180095070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103948s5070lbl.pdf 9/26/2007
AP09/19/2007S315645070   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/103948Orig1s5070.pdf 1/27/2012
AP011/14/2014SLR409975139   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103948s5139lbl.pdf 11/17/2014
AP011/14/2014SLR410005139   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103948Orig1s5139ltr.pdf 11/17/2014
AP011/14/2014SLR412075139   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426512.pdf 12/11/2014
AP09/5/2014SLR404595150   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103948s5150lbl.pdf 9/9/2014
AP09/5/2014SLR404755150   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103948Orig1s5150,s5143ltr.pdf 9/10/2014
AP09/18/2015S439385151   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103948Orig1s5151ltr.pdf 9/22/2015
AP04/5/2016S456315153   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103948Orig1s5153ltr.pdf 4/11/2016




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