NDC 49288-0831

Treatment Set TS344059

Treatment Set Ts344059

Treatment Set TS344059 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 Felis Catus Hair; Ambrosia Artemisiifolia Pollen; Aspergillus Fumigatus; Alternaria Alternata.

Product ID49288-0831_f38e0c9c-da50-41d7-a0c6-506be87d4981
NDC49288-0831
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS344059
Generic NameTreatment Set Ts344059
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameFELIS CATUS HAIR; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA
Active Ingredient Strength2000 [BAU]/mL; [AU]/mL; g/mL; g/mL
Pharm ClassesStandardized 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],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],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 49288-0831-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0831-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0831-3 [49288083103]

Treatment Set TS344059 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
FELIS CATUS HAIR2000 [BAU]/mL

OpenFDA Data

SPL SET ID:51b3476c-15cd-4db2-a06b-b3b64a8bf39c
Manufacturer
UNII

Pharmacological Class

  • 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]
  • 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]
  • 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]

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