Sargramostim - Leucotropin; Granulocyte/Macrophage Colony Stimulating Factor, recombinant; GM-CSF -- Product Record

GM-CSF, rDNA/Cangene

    Nomenclature:
      GM-CSF, rDNA/Cangene [BIO]
      Leucotropin [TR]
      Sargramostim [FDA]
      granulocyte-macrophage colony stimulating factor, recombinant [SY]
      rhGM-CSF [SY]

    FDA Class:  Biologic BLA

Index Terms:

  • Product Class Index:
      biopharmaceutical products
      Biorex-70 resin
      exempt from CBER lot release requirements
      growth factors, hematopoietic
      recombinant DNA
  • Biological Index:
      bacterial culture <!-- bacterialculture -->
      streptolysin O
  • Chemical Index:
  • Source/Host/Expression System: Streptomyces micbacstrep
  • Regulatory/Status Index:
      BHK-21 (C-13)
      North American coral snake
      North American coral snake
      EU000 Not yet/Never filed with EU
      UM999 Not Available/Not Marketed in US
      US000 never filed/no plans
      EM999 Not Available/Not Marketed in EU