NDC 0268-8074

MIX OF 6 STANDARD GRASS POLLEN

Agrostis Gigantea Pollen, Dactylis Glomerata Pollen, Festuca Pratensis, Lolium Perenne Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen

MIX OF 6 STANDARD GRASS POLLEN is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense Pollen; Dactylis Glomerata Pollen; Poa Pratensis Pollen; Agrostis Gigantea Pollen; Festuca Pratensis Pollen; Lolium Perenne Pollen.

Product ID0268-8074_0d292dae-220a-45c7-94cb-cade20038419
NDC0268-8074
Product TypeStandardized Allergenic
Proprietary NameMIX OF 6 STANDARD GRASS POLLEN
Generic NameAgrostis Gigantea Pollen, Dactylis Glomerata Pollen, Festuca Pratensis, Lolium Perenne Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1997-12-18
Marketing CategoryBLA / BLA
Application NumberBLA103058
Labeler NameALK-Abello, Inc.
Substance NamePHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN
Active Ingredient Strength16667 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
Pharm ClassesStandardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0268-8074-06

5.5 mL in 1 VIAL (0268-8074-06)
Marketing Start Date1997-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8074-06 [00268807406]

MIX OF 6 STANDARD GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

NDC 0268-8074-10 [00268807410]

MIX OF 6 STANDARD GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

NDC 0268-8074-50 [00268807450]

MIX OF 6 STANDARD GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE POLLEN16667 [BAU]/mL

Pharmacological Class

  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]

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