NDC 49288-0924

Treatment Set TS349815

Treatment Set Ts349815

Treatment Set TS349815 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 Dermatophagoides Farinae; Penicillium Chrysogenum Var. Chrysogenum; Aspergillus Fumigatus.

Product ID49288-0924_e266b12c-c311-4e1b-9d5a-1f448a15eb0e
NDC49288-0924
Product TypeNon-standardized Allergenic
Proprietary NameTreatment Set TS349815
Generic NameTreatment Set Ts349815
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameDERMATOPHAGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; ASPERGILLUS FUMIGATUS
Active Ingredient Strength2000 [AU]/mL; g/mL; g/mL
Pharm ClassesAllergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0924-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0924-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0924-3 [49288092403]

Treatment Set TS349815 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1986-10-31
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES FARINAE2000 [AU]/mL

Pharmacological Class

  • Allergens [CS]
  • Insect Proteins [CS]
  • Standardized Insect Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Antigens
  • Dermatophagoides [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]

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