NDC 49288-0763

Treatment Set TS329240

Treatment Set Ts329240

Treatment Set TS329240 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 Ambrosia Trifida Pollen; Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen; Carya Illinoinensis Pollen; Carya Alba Pollen; Pleospora Herbarum; Penicillium Chrysogenum Var. Chrysogenum; Juniperus Virginiana Pollen; Quercus Alba Pollen; Fraxinus Americana Pollen; Ulmus Americana Pollen; Poa Pratensis Pollen; Cynodon Dactylon Pollen; Dermatophagoides Pteronyssinus; Plantago Lanceolata Pollen; Phoma Destructiva; Candida Albicans; Kochia Scoparia Pollen; Acer Negundo Pollen; Populus Deltoides Pollen; Betula Nigra Pollen; Sorghum Halepense Pollen; Chenopodium Album Pollen; Iva Annua Var. Annua Pollen; Amaranthus Retroflexus Pollen; Salsola Kali Pollen.

Product ID49288-0763_b29faef0-2249-45b7-974b-212faa8c91d8
NDC49288-0763
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS329240
Generic NameTreatment Set Ts329240
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameAMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLEOSPORA HERBARUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; PHOMA DESTRUCTIVA; CANDIDA ALBICANS; KOCHIA SCOPARIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN
Active Ingredient Strength0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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],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 Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal 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],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],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 Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [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],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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 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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0763-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0763-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0763-3 [49288076303]

Treatment Set TS329240 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
AMBROSIA TRIFIDA POLLEN.0000267 g/mL

OpenFDA Data

SPL SET ID:4774e45e-d34c-4520-bf4c-6f46e98a0a8c
Manufacturer
UNII
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]
    • 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]
    • 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 Fungal Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Fungal 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]
    • 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]
    • 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 Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [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]
    • Non-Standardized Fungal Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Fungal Proteins [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 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]
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