Orchard Grass, Standardized is a Percutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Allergenic Extract- Orchard Grass Dactylis Glomerata.
| Product ID | 0268-3056_13f1ef62-876b-4a9f-90cd-bb7e307157e9 |
| NDC | 0268-3056 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Orchard Grass, Standardized |
| Generic Name | Orchard Grass, Standardized |
| Dosage Form | Solution |
| Route of Administration | PERCUTANEOUS |
| Marketing Start Date | 1997-12-18 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103054 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA |
| Active Ingredient Strength | 10000 [BAU]/mL |
| Pharm Classes | 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 | 2018-12-31 |
| Marketing Start Date | 1997-12-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103054 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1997-12-18 |
| Marketing End Date | 2019-10-17 |
| Ingredient | Strength |
|---|---|
| ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA | 10000 [BAU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-0281 | Orchard Grass, Standardized | Orchard Grass, Standardized |
| 0268-0282 | Orchard Grass, Standardized | Orchard Grass, Standardized |
| 0268-3055 | Orchard Grass, Standardized | Orchard Grass, Standardized |
| 0268-3056 | Orchard Grass, Standardized | Orchard Grass, Standardized |