NDC 49288-0781

Treatment Set TS335683

Treatment Set Ts335683

Treatment Set TS335683 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 Cynodon Dactylon Pollen; Phleum Pratense Pollen.

Product ID49288-0781_52150fa7-4a21-4e92-8659-4277b21eff92
NDC49288-0781
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS335683
Generic NameTreatment Set Ts335683
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameCYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN
Active Ingredient Strength2000 [BAU]/mL; [BAU]/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],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 49288-0781-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0781-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0781-3 [49288078103]

Treatment Set TS335683 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
CYNODON DACTYLON POLLEN2000 [BAU]/mL

OpenFDA Data

SPL SET ID:d32eec3b-6976-474c-a5a2-af67b6965284
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1192754
  • 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

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

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