NDC 49288-0792

Treatment Set TS337554

Treatment Set Ts337554

Treatment Set TS337554 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; Quercus Alba Pollen.

Product ID49288-0792_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee
NDC49288-0792
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS337554
Generic NameTreatment Set Ts337554
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS; QUERCUS ALBA POLLEN
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 Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0792-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0792-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0792-3 [49288079203]

Treatment Set TS337554 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS2000 [AU]/mL

OpenFDA Data

SPL SET ID:3bfb5be4-542a-4b86-beac-688a07fc830c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1192793
  • 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 Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]

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