NDC 49288-0953

Treatment Set TS351167

Treatment Set Ts351167

Treatment Set TS351167 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 Plantago Lanceolata Pollen; Amaranthus Retroflexus Pollen; Ambrosia Artemisiifolia Pollen; Rumex Acetosella Pollen; Festuca Pratensis Pollen; Phleum Pratense Pollen; Pascopyrum Smithii Pollen; Felis Catus Hair; Canis Lupus Familiaris Hair; Alternaria Alternata; Aspergillus Fumigatus; Cochliobolus Sativus; Acer Negundo Pollen; Populus Deltoides Pollen; Ulmus Americana Pollen; Quercus Alba Pollen; Morus Rubra Pollen; Equus Caballus Hair; Gallus Gallus Feather; Anser Anser Feather; Anas Platyrhynchos Feather; Oryctolagus Cuniculus Hair; Odocoileus Virginianus Hair; Bos Taurus Hair.

Product ID49288-0953_57885b81-24e5-4a64-8d65-8a6517157bd9
NDC49288-0953
Product TypeNon-standardized Allergenic
Proprietary NameTreatment Set TS351167
Generic NameTreatment Set Ts351167
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NamePLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; MORUS RUBRA POLLEN; EQUUS CABALLUS HAIR; GALLUS GALLUS FEATHER; ANSER ANSER FEATHER; ANAS PLATYRHYNCHOS FEATHER; ORYCTOLAGUS CUNICULUS HAIR; ODOCOILEUS VIRGINIANUS HAIR; BOS TAURUS HAIR
Active Ingredient Strength0 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/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; g/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],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],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [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 Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [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],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 Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [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],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS],Salivary Proteins and Peptides [CS],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0953-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0953-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0953-3 [49288095303]

Treatment Set TS351167 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1986-10-31
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
PLANTAGO LANCEOLATA POLLEN.002 g/mL

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

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