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FDA Drug Application 103950 by BIOVITRUM AB

Application Number103950
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
AP011/14/2001N79760000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/anakamg111401L.htm 3/17/2004
AP011/14/2001N79770000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401LB.pdf 3/17/2004
AP011/14/2001N79780000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401ptLB.pdf 3/17/2004
AP011/14/2001N114730000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103950-0_Kineret.cfm 4/27/2005
AP06/27/2003S79795013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/anakamg062703L.htm 3/17/2004
AP06/27/2003S79805013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/anakamg062703LB.pdf 3/17/2004
AP08/21/2003S68915019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103950-5019ltr.pdf 11/6/2003
AP04/23/2004S104375039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039lbl.pdf 10/21/2004
AP04/23/2004S104385039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039ppi.pdf 10/21/2004
AP04/23/2004S104625039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103950_5039ltr.pdf 10/26/2004
AP09/23/2011S301485116   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103950s5116lbl.pdf 9/30/2011
AP012/21/2012SE1347855136   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103950Orig1s5136ltr.pdf 12/28/2012
AP012/21/2012SE1347985136   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf 12/28/2012
AP010/23/2013SLR375575150   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103950Orig1s5150ltr.pdf 10/25/2013
AP010/23/2013SLR375845150   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5150lbl.pdf 10/25/2013
AP05/19/2016SLR460805175   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103950Orig1s5175ltr.pdf 5/20/2016
AP05/19/2016SLR461005175   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103950s5175lbl.pdf 5/23/2016




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