NDC 49288-0916

Treatment Set TS349575

Treatment Set Ts349575

Treatment Set TS349575 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 Cynodon Dactylon Pollen; Avena Sativa Pollen; Phleum Pratense Pollen; Pascopyrum Smithii Pollen; Felis Catus Hair; Canis Lupus Familiaris Hair; Dermatophagoides Pteronyssinus; Alternaria Alternata; Aspergillus Fumigatus; Cladosporium Herbarum; Cochliobolus Sativus.

Product ID49288-0916_c3d917bc-fa5c-42d8-aef9-5973a92fcb55
NDC49288-0916
Product TypeNon-standardized Allergenic
Proprietary NameTreatment Set TS349575
Generic NameTreatment Set Ts349575
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameCYNODON DACTYLON POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS
Active Ingredient Strength400 [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL
Pharm ClassesIncreased 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 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],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 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 Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0916-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0916-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0916-3 [49288091603]

Treatment Set TS349575 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1986-10-31
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
CYNODON DACTYLON POLLEN400 [BAU]/mL

Pharmacological Class

  • 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 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]
  • 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 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 Fungal Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Fungal Proteins [CS]
  • Allergens [CS]

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.