NDC 49288-0788

Treatment Set TS336682

Treatment Set Ts336682

Treatment Set TS336682 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 Felis Catus Hair; Canis Lupus Familiaris Hair; Cynodon Dactylon Pollen; Sorghum Halepense Pollen; Poa Pratensis Pollen; Paspalum Notatum Pollen; Dermatophagoides Farinae; Dermatophagoides Pteronyssinus; Rhizopus Stolonifer; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen.

• Product ID: 49288-0788_b4053499-e3af-4991-9c56-5eb96ac94dca
• NDC: 49288-0788
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS336682
• Generic Name: Treatment Set Ts336682
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1986-10-31
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; PASPALUM NOTATUM POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; RHIZOPUS STOLONIFER; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN
• Active Ingredient Strength: 400 [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
• Pharm Classes: Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [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],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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0788-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0788-3)

• Marketing Start Date: 1986-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0788-3 [49288078803]

Treatment Set TS336682 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-10-31
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
FELIS CATUS HAIR	400 [BAU]/mL

OpenFDA Data

• SPL SET ID: 400bff34-d1a7-420e-9635-3119313cea5e
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 23H70FYJ5U
  • 700NK45C76
  • 1564HD0N96
  • 098LKX5NCN
  • 89BAT511BD
  • V003SHB7VK
  • 577VA5B4HP
  • Z4Y9ZSV4KK
  • G684LX721Q
  • DO87T1U2CI
  • PYO4JR720Y
  • 83N78IDA7P
  • PY0JA16R2G
  • PR9U2YPF3Q
  • 65M88RW2EG
  • K20Y81ACO3
  • SCB8J7LS3T
  • 175F461W10
  • FEE198DK4Q
  • 57L1Z5378K
  • 2MH135KC6G
  • N52MIQ81ZW
  • 05S7L91ZTR
  • 52B29REC7H
  • 476DVV63WP
  • 4T81LB52R0
  • 73B14PX5FW

Pharmacological Class

• Standardized Animal Hair Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Dander [CS]
• Allergens [CS]
• Salivary Proteins and Peptides [CS]
• Non-Standardized Animal Hair Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Animal Fur [CS]
• Allergens [CS]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [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]
• 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]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]