Standardized Grass Pollen, Bluegrass, Kentucky June is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Poa Pratensis Pollen.
| Product ID | 65044-0545_0cdf6656-6263-450e-a312-5cb125444591 |
| NDC | 65044-0545 |
| Product Type | Standardized Allergenic |
| Proprietary Name | Standardized Grass Pollen, Bluegrass, Kentucky June |
| Generic Name | Standardized Grass Pollen, Bluegrass, Kentucky June |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 1998-01-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103873 |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | POA PRATENSIS POLLEN |
| 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 | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 1998-01-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103873 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1998-01-15 |
| Marketing Category | BLA |
| Application Number | BLA103873 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1998-01-15 |
| Marketing Category | BLA |
| Application Number | BLA103873 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1998-01-15 |
| Marketing Category | BLA |
| Application Number | BLA103873 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1998-01-15 |
| Ingredient | Strength |
|---|---|
| POA PRATENSIS POLLEN | 10000 [BAU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65044-0545 | Standardized Grass Pollen, Bluegrass, Kentucky June | Standardized Grass Pollen, Bluegrass, Kentucky June |
| 65044-0546 | Standardized Grass Pollen, Bluegrass, Kentucky June | Standardized Grass Pollen, Bluegrass, Kentucky June |
| 65044-0547 | Standardized Grass Pollen, Bluegrass, Kentucky June | Standardized Grass Pollen, Bluegrass, Kentucky June |
| 65044-0548 | Standardized Grass Pollen, Bluegrass, Kentucky June | Standardized Grass Pollen, Bluegrass, Kentucky June |