NDC 49288-0833

Treatment Set TS344420

Treatment Set Ts344420

Treatment Set TS344420 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 Periplaneta Americana; Dermatophagoides Farinae; Dermatophagoides Pteronyssinus; Fusarium Oxysporum; Cochliobolus Sativus.

Product ID49288-0833_f38e0c9c-da50-41d7-a0c6-506be87d4981
NDC49288-0833
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS344420
Generic NameTreatment Set Ts344420
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NamePERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS
Active Ingredient Strength0 g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL
Pharm ClassesNon-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS],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],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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0833-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0833-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0833-3 [49288083303]

Treatment Set TS344420 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
PERIPLANETA AMERICANA.002 g/mL

OpenFDA Data

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

Pharmacological Class

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