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FDA Drug Application 125370 by HUMAN GENOME SCIENCES INC.

Application Number125370
Application Type Biologic License Application
Sponsor ApplicantHUMAN GENOME SCIENCES INC.
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
AP03/9/2011N28224000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf 3/11/2011
AP03/9/2011N28225000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000MedG.pdf 3/11/2011
AP03/9/2011N28251000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125370s000ltr.pdf 3/16/2011
AP03/9/2011N28598000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000TOC.cfm 4/22/2011
AP03/9/2011N28599000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000SumR.pdf 4/22/2011
AP03/30/2012SLR32331016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf 4/2/2012
AP03/30/2012SLR32336016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125370s016ltr.pdf 4/2/2012
AP012/13/2013SLR38062047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125370Orig1s047ltr.pdf 12/17/2013
AP012/13/2013SLR38090047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf 12/17/2013
AP04/3/2014SLR38972053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf 4/4/2014
AP04/3/2014SLR38977053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125370Orig1s053ltr.pdf 4/4/2014




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