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FDA Drug Application 125103 by BIOVITRUM AB

Application Number125103
Application Type Biologic License Application
Sponsor ApplicantBIOVITRUM AB
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
AP012/15/2004N108150000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125103_0000_ltr.pdf 12/29/2004
AP012/15/2004N108350000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125103lbl.pdf 12/29/2004
AP012/15/2004N122940000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110263.htm 7/28/2005
AP012/15/2004N128200000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125103s000_KepivanceTOC.cfm 9/26/2005
AP012/12/2005S132900010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125103s0010ltr.pdf 12/16/2005
AP012/12/2005S132950010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125103s0010lbl.pdf 12/16/2005
AP09/23/2011S301490018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0118lbl.pdf 9/30/2011
AP011/18/2011S307220120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0120lbl.pdf 11/21/2011
AP011/18/2011S307470120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125103s0120ltr.pdf 11/22/2011
AP05/30/2013SLR36172146   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125103Orig1s146ltr.pdf 5/31/2013
AP05/30/2013SLR36214146   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125103s146lbl.pdf 6/4/2013
AP03/13/2015SLR42152167   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125103Orig1s167ltr.pdf 3/16/2015
AP07/1/2016SLR46452171   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125103Orig1s171,s172ltr.pdf 7/5/2016
AP07/1/2016SLR46463171   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf 7/5/2016
AP07/1/2016SLR46464172   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf 7/5/2016




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