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Treatment Set TS348491 - 49288-0898-3 - (Treatment Set TS348491)

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Drug Information Labeler Information Package Information NDC Record

Drug Information of Treatment Set TS348491

Product NDC: 49288-0898
Proprietary Name: Treatment Set TS348491
Non Proprietary Name: Treatment Set TS348491
Active Ingredient(s): .002; .0004; .01; .01; 16; 400; 400; 400; 800; .002; 800; .00008    g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL & nbsp;   Treatment Set TS348491
Administration Route(s): INTRADERMAL; SUBCUTANEOUS
Dosage Form(s): INJECTION, SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Treatment Set TS348491

Product NDC: 49288-0898
Labeler Name: Antigen Laboratories, Inc.
Product Type: NON-STANDARDIZED ALLERGENIC
FDA Application Number: BLA102223
Marketing Category: BLA
Start Marketing Date: 20121116

Package Information of Treatment Set TS348491

Package NDC: 49288-0898-3
Package Description: 10 mL in 1 VIAL, MULTI-DOSE (49288-0898-3)

NDC Information of Treatment Set TS348491

NDC Code 49288-0898-3
Proprietary Name Treatment Set TS348491
Package Description 10 mL in 1 VIAL, MULTI-DOSE (49288-0898-3)
Product NDC 49288-0898
Product Type Name NON-STANDARDIZED ALLERGENIC
Non Proprietary Name Treatment Set TS348491
Dosage Form Name INJECTION, SOLUTION
Route Name INTRADERMAL; SUBCUTANEOUS
Start Marketing Date 20121116
Marketing Category Name BLA
Labeler Name Antigen Laboratories, Inc.
Substance Name ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN
Strength Number .002; .0004; .01; .01; 16; 400; 400; 400; 800; .002; 800; .00008
Strength Unit g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL
Pharmaceutical Classes Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Protein Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Protein Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient]

Complete Information of Treatment Set TS348491


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