NDC 49288-0695

Treatment Set TS332509

Treatment Set Ts332509

Treatment Set TS332509 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 Fraxinus Americana Pollen; Quercus Alba Pollen; Populus Deltoides Pollen; Betula Nigra Pollen; Poa Pratensis Pollen; Cynodon Dactylon Pollen; Sorghum Halepense Pollen; Dermatophagoides Pteronyssinus; Dermatophagoides Farinae; Felis Catus Hair; Gallus Gallus Feather; Anas Platyrhynchos Feather; Anser Anser Feather.

Product ID49288-0695_89f9e682-acd9-4cc7-982d-c32f69b33b07
NDC49288-0695
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS332509
Generic NameTreatment Set Ts332509
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameFRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER
Active Ingredient Strength0 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL
Pharm ClassesNon-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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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 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],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [CS],Allergens [CS],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0695-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0695-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0695-3 [49288069503]

Treatment Set TS332509 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
FRAXINUS AMERICANA POLLEN.002 g/mL

OpenFDA Data

SPL SET ID:ed4d2a22-6a86-48b6-97c0-7774c659120f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1192833
  • 1192780
  • 1191210
    • Pharm Class PE
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Increased Histamine Release [PE]
    • PHarm Class EPC
  • Non-Standardized Fungal Allergenic Extract [EPC]
    • NUI Code
  • N0000185001
  • N0000175629
  • N0000171131
  • N0000185372
  • N0000169106
  • N0000184306

    • Pharmacological Class

    • 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 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]
    • 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 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]
    • Standardized Animal Hair Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Dander [CS]
    • Allergens [CS]
    • Salivary Proteins and Peptides [CS]
    • Non-Standardized Feather Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Feathers [CS]
    • Allergens [CS]
    • Non-Standardized Feather Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Feathers [CS]
    • Allergens [CS]
    • Increased IgG Production [PE]
    • Non-Standardized Feather Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Feathers [CS]
    • Allergens [CS]
    • Increased IgG Production [PE]
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