NDC 49288-0877

Treatment Set TS347337

Treatment Set Ts347337

Treatment Set TS347337 is a Intradermal; Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Cynodon Dactylon Pollen; Festuca Pratensis Pollen; Sorghum Halepense Pollen; Avena Sativa Pollen; Pascopyrum Smithii Pollen; Canis Lupus Familiaris Hair; Dermatophagoides Pteronyssinus; Alternaria Alternata.

Product ID49288-0877_f6f33373-7c0b-4834-add6-a7c79d24e403
NDC49288-0877
Product TypeNon-standardized Allergenic
Proprietary NameTreatment Set TS347337
Generic NameTreatment Set Ts347337
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameCYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PASCOPYRUM SMITHII POLLEN; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA
Active Ingredient Strength80 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0877-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0877-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0877-3 [49288087703]

Treatment Set TS347337 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1986-10-31
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
CYNODON DACTYLON POLLEN80 [BAU]/mL

Pharmacological Class

  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Animal Hair Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Animal Fur [CS]
  • Allergens [CS]
  • Standardized Insect Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Antigens
  • Dermatophagoides [CS]
  • Insect Proteins [CS]
  • Allergens [CS]
  • Non-Standardized Fungal Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Fungal Proteins [CS]
  • Allergens [CS]

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