NDC 49288-0854

Treatment Set TS346157

Treatment Set Ts346157

Treatment Set TS346157 is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus; Dermatophagoides Farinae; Canis Lupus Familiaris Hair; Cynodon Dactylon Pollen; Phleum Pratense Pollen; Ambrosia Artemisiifolia Pollen; Iva Annua Pollen.

Product ID49288-0854_bfb6bdbb-da65-4cb3-a50d-250270cdd448
NDC49288-0854
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS346157
Generic NameTreatment Set Ts346157
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA POLLEN
Active Ingredient Strength1000 [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL
Pharm ClassesStandardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [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],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],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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0854-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0854-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0854-3 [49288085403]

Treatment Set TS346157 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS1000 [AU]/mL

OpenFDA Data

SPL SET ID:40631eff-c151-4f94-ade6-6ad2eaced01a
Manufacturer
UNII

Pharmacological Class

  • 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]
  • Allergens [CS]
  • Insect Proteins [CS]
  • Standardized Insect Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Antigens
  • Dermatophagoides [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]
  • 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]
  • 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]

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