NDC 49288-0938

Treatment Set TS350565

Treatment Set Ts350565

Treatment Set TS350565 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 Pteronyssinus; Cochliobolus Sativus; Penicillium Chrysogenum Var. Chrysogenum.

Product ID49288-0938_6e25c8e0-c526-446a-ae3c-33c3078f6714
NDC49288-0938
Product TypeNon-standardized Allergenic
Proprietary NameTreatment Set TS350565
Generic NameTreatment Set Ts350565
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS; COCHLIOBOLUS SATIVUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Active Ingredient Strength400 [AU]/mL; g/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 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 49288-0938-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0938-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0938-3 [49288093803]

Treatment Set TS350565 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 PTERONYSSINUS400 [AU]/mL

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 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]

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