Treatment Set TS333938 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 Dermatophagoides Pteronyssinus; Ambrosia Trifida Pollen; Ambrosia Bidentata Pollen; Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen; Iva Xanthifolia Pollen; Iva Annua Var. Annua Pollen; Salsola Kali Pollen; Plantago Lanceolata Pollen; Fagus Grandifolia Pollen; Platanus Occidentalis Pollen; Juglans Nigra Pollen; Salix Nigra Pollen; Carpinus Caroliniana Pollen; Picea Pungens Pollen; Acer Negundo Pollen; Pinus Strobus Pollen; Celtis Occidentalis Pollen; Acer Saccharum Pollen; Juniperus Ashei Pollen; Betula Papyrifera Pollen; Juniperus Virginiana Pollen; Acer Rubrum Pollen; Morus Rubra Pollen; Juniperus Pinchotii Pollen; Carya Ovata Pollen; Acer Saccharinum Pollen; Liquidambar Styraciflua Pollen; Ailanthus Altissima Pollen; Fraxinus Americana Pollen; Carya Alba Pollen; Morus Alba Pollen; Populus Alba Pollen; Alternaria Alternata; Aspergillus Flavus; Aspergillus Fumigatus; Aspergillus Niger Var. Niger; Aspergillus Repens; Fusarium Oxysporum; Cochliobolus Sativus; Cladosporium Cladosporioides; Mucor Racemosus; Penicillium Camemberti; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Expansum; Penicillium Italicum; Penicillium Chrysogenum Var. Chrysogenum; Penicillium Roqueforti; Phoma Destructiva; Aureobasidium Pullulans Var. Pullutans; Rhizopus Stolonifer; Cynodon Dactylon Pollen; Lolium Perenne Pollen; Agrostis Gigantea Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen; Festuca Pratensis Pollen; Poa Pratensis Pollen; Anthoxanthum Odoratum Pollen; Poa Compressa Pollen; Typha Latifolia Pollen; Bromus Secalinus Pollen; Zea Mays Pollen; Secale Cereale Pollen; Triticum Aestivum Pollen; Sorghum Halepense Pollen; Elymus Repens Pollen; Phalaris Arundinacea Pollen; Bromus Inermis Pollen; Sorghum Bicolor Ssp. Drummondii Pollen; Arrhenatherum Elatius Pollen; Holcus Lanatus Pollen; Pascopyrum Smithii Pollen.
| Product ID | 49288-0657_89f9e682-acd9-4cc7-982d-c32f69b33b07 |
| NDC | 49288-0657 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Treatment Set TS333938 |
| Generic Name | Treatment Set Ts333938 |
| 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 | DERMATOPHAGOIDES PTERONYSSINUS; AMBROSIA TRIFIDA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; ACER NEGUNDO POLLEN; PINUS STROBUS POLLEN; CELTIS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; JUNIPERUS ASHEI POLLEN; BETULA PAPYRIFERA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; JUNIPERUS PINCHOTII POLLEN; CARYA OVATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN; ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; CYNODON DACTYLON POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; POA COMPRESSA POLLEN; TYPHA LATIFOLIA POLLEN; BROMUS SECALINUS POLLEN; ZEA MAYS POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; SORGHUM HALEPENSE POLLEN; ELYMUS REPENS POLLEN; PHALARIS ARUNDINACEA POLLEN; BROMUS INERMIS POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN |
| Active Ingredient Strength | 1000 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL |
| Pharm Classes | 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 Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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],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],Non-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],Non-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],Non-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],Non-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],Non-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],Non-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],Non-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],Non-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],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-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] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 1986-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1986-10-31 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| DERMATOPHAGOIDES PTERONYSSINUS | 1000 [AU]/mL |