Kentucky bluegrass pollen extract / orchard grass pollen extract / perennial rye grass pollen extract / sweet vernal grass pollen extract / Timothy grass pollen extract Sublingual Tablet

Brand(s)
Oralair 100, Oralair 300
Category(s)
other
SPL Type(s)
Standardized Allergenic
Master SPL
Stallergenes S.A (2015-01-14)
Oldest Current Product
2014-04-30
License(s)
BLA
RxNORM
SUBLINGUAL TABLET\KENTUCKY BLUEGRASS POLLEN EXTRACT:ORCHARD GRASS POLLEN EXTRACT:PERENNIAL RYE GRASS POLLEN EXTRACT:SWEET VERNAL GRASS POLLEN EXTRACT:TIMOTHY GRASS POLLEN EXTRACT
SPL Active
SUBLINGUAL\TABLET, ORALLY DISINTEGRATING\ANTHOXANTHUM ODORATUM POLLEN: DACTYLIS GLOMERATA POLLEN: LOLIUM PERENNE POLLEN: PHLEUM PRATENSE POLLEN: POA PRATENSIS POLLEN
SPL Moiety
SUBLINGUAL\TABLET, ORALLY DISINTEGRATING\ANTHOXANTHUM ODORATUM POLLEN: DACTYLIS GLOMERATA POLLEN: LOLIUM PERENNE POLLEN: PHLEUM PRATENSE POLLEN: POA PRATENSIS POLLEN

product(s) by strength(s)

kentucky bluegrass pollen extract 100 ir / orchard grass pollen extract 100 ir / perennial rye grass pollen extract 100 ir / sweet vernal grass pollen extract 100 ir / timothy grass pollen extract 100 ir sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596170010Oralair 100BLAStallergenes S.A2014-04-30ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLENSUBLINGUALTABLET, ORALLY DISINTEGRATING125471854c9772-63b9-44a3-a11e-77b29c59e91d

kentucky bluegrass pollen extract 300 ir / orchard grass pollen extract 300 ir / perennial rye grass pollen extract 300 ir / sweet vernal grass pollen extract 300 ir / timothy grass pollen extract 300 ir sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596170015Oralair 300BLAStallergenes S.A2014-04-30ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLENSUBLINGUALTABLET, ORALLY DISINTEGRATING125471854c9772-63b9-44a3-a11e-77b29c59e91d
2596170025Oralair 300BLAStallergenes S.A2014-04-30ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLENSUBLINGUALTABLET, ORALLY DISINTEGRATING125471854c9772-63b9-44a3-a11e-77b29c59e91d

application(s)

#idtitleapprovedtradenamesfda division
1125471Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Application2014-04-01ORALAIRCBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1854c9772-63b9-44a3-a11e-77b29c59e91d (view SPL)These highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR. ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)Tablet for Sublingual Use Initial U.S. Approval: 2014otherStandardized AllergenicStallergenes S.A2015-01-143596170010, 596170015, 596170025, 596170016, 596170020

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII