NDC 49288-0838

Treatment Set TS344592

Treatment Set Ts344592

Treatment Set TS344592 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 Dermatophagoides Pteronyssinus; Canis Lupus Familiaris Hair.

Product ID49288-0838_9a8e59e8-156a-4999-a000-b68054b405d3
NDC49288-0838
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS344592
Generic NameTreatment Set Ts344592
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR
Active Ingredient Strength2000 [AU]/mL; g/mL
Pharm ClassesStandardized 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 Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0838-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0838-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0838-3 [49288083803]

Treatment Set TS344592 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS2000 [AU]/mL

OpenFDA Data

SPL SET ID:354ef6d9-c531-4958-bc94-00e52569c0e1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248605
  • 1248595
  • 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

    • 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 Animal Hair Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Animal Fur [CS]
    • Allergens [CS]

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