NDC 49288-0242

Mixture of Standardized and Non-Standardized Coastal Grasses

Mixture Of Standardized And Non-standardized Coastal Grasses

Mixture of Standardized and Non-Standardized Coastal Grasses 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 Poa Pratensis Pollen; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Phleum Pratense Pollen; Poa Compressa Pollen; Arrhenatherum Elatius Pollen; Holcus Lanatus Pollen.

Product ID49288-0242_bb0c98b2-aaa8-49c4-887a-928e3937769c
NDC49288-0242
Product TypeHuman Prescription Drug
Proprietary NameMixture of Standardized and Non-Standardized Coastal Grasses
Generic NameMixture Of Standardized And Non-standardized Coastal Grasses
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1997-06-13
Marketing CategoryBLA / BLA
Application NumberBLA103421
Labeler NameAntigen Laboratories, Inc.
Substance NamePOA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN
Active Ingredient Strength11111 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL
Pharm ClassesStandardized 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],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],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],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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0242-5

50 mL in 1 VIAL, MULTI-DOSE (49288-0242-5)
Marketing Start Date1997-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0242-4 [49288024204]

Mixture of Standardized and Non-Standardized Coastal Grasses INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0242-3 [49288024203]

Mixture of Standardized and Non-Standardized Coastal Grasses INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0242-5 [49288024205]

Mixture of Standardized and Non-Standardized Coastal Grasses INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
POA PRATENSIS POLLEN11111 [BAU]/mL

OpenFDA Data

SPL SET ID:c08f73ff-4f15-449c-9507-c422367f106b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 853027
  • 854054
  • 851873
  • 853047
  • 897496
  • 854162
  • 853278
  • 852157
  • Pharmacological Class

    • 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]
    • 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]
    • 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]
    • 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]

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