NDC 59617-0016

Oralair 300 IR

Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen

Oralair 300 IR is a Sublingual Tablet, Orally Disintegrating in the Standardized Allergenic category. It is labeled and distributed by Stallergenes. The primary component is Anthoxanthum Odoratum Pollen; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen.

Product ID59617-0016_08317321-144b-488d-8756-6f847731ae45
NDC59617-0016
Product TypeStandardized Allergenic
Proprietary NameOralair 300 IR
Generic NameAnthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen
Dosage FormTablet, Orally Disintegrating
Route of AdministrationSUBLINGUAL
Marketing Start Date2014-04-30
Marketing CategoryBLA / BLA
Application NumberBLA125471
Labeler NameStallergenes
Substance NameANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
Active Ingredient Strength300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1
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],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 59617-0016-1

1 BLISTER PACK in 1 BOX (59617-0016-1) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2014-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59617-0016-1 [59617001601]

Oralair 300 IR TABLET, ORALLY DISINTEGRATING
Marketing CategoryBLA
Application NumberBLA125471
Product TypeSTANDARDIZED ALLERGENIC
Billing UnitEA
Marketing Start Date2014-04-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ANTHOXANTHUM ODORATUM POLLEN300 [IR]/1

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

NDC Crossover Matching brand name "Oralair 300 IR" or generic name "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen"

NDCBrand NameGeneric Name
59617-0010OralairANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0015OralairANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0016OralairANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0020OralairANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0025OralairANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
82454-0015OralairANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN

Trademark Results [Oralair]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORALAIR
ORALAIR
85807637 4593632 Live/Registered
STALLERGENES
2012-12-20
ORALAIR
ORALAIR
79012205 3194354 Live/Registered
STALLERGENES
2005-06-02

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