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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 596170010 | Oralair 100 | BLA | Stallergenes S.A | 2014-04-30 | ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN | SUBLINGUAL | TABLET, ORALLY DISINTEGRATING | 125471 | 854c9772-63b9-44a3-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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 596170015 | Oralair 300 | BLA | Stallergenes S.A | 2014-04-30 | ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN | SUBLINGUAL | TABLET, ORALLY DISINTEGRATING | 125471 | 854c9772-63b9-44a3-a11e-77b29c59e91d |
| 2 | 596170025 | Oralair 300 | BLA | Stallergenes S.A | 2014-04-30 | ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN | SUBLINGUAL | TABLET, ORALLY DISINTEGRATING | 125471 | 854c9772-63b9-44a3-a11e-77b29c59e91d |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125471 | Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Application | 2014-04-01 | ORALAIR | CBER |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 854c9772-63b9-44a3-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: 2014 | other | Standardized Allergenic | Stallergenes S.A | 2015-01-14 | 3 | 596170010, 596170015, 596170025, 596170016, 596170020 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII