Standardized Timothy Grass Pollen is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Phleum Pratense Pollen.
| Product ID | 36987-2401_1ec687f1-9d85-476a-83e1-59e2bdbeebbc |
| NDC | 36987-2401 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Standardized Timothy Grass Pollen |
| Generic Name | Standardized Timothy Grass Pollen |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1998-02-10 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102202 |
| Labeler Name | Nelco Laboratories, Inc. |
| Substance Name | PHLEUM PRATENSE POLLEN |
| Active Ingredient Strength | 100000 [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 | 2017-12-31 |
| Marketing Start Date | 1998-02-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA102202 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1998-02-10 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102202 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1998-02-10 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102202 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1998-02-10 |
| Inactivation Date | 2019-10-21 |
| Marketing Category | BLA |
| Application Number | BLA102202 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1998-02-10 |
| Inactivation Date | 2019-10-21 |
| Ingredient | Strength |
|---|---|
| PHLEUM PRATENSE POLLEN | 100000 [BAU]/mL |
| SPL SET ID: | 6a9c78b4-97a6-4fbc-a072-8916f7232b1b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36987-2401 | Standardized Timothy Grass Pollen | Standardized Timothy Grass Pollen |
| 36987-2402 | Standardized Timothy Grass Pollen | Standardized Timothy Grass Pollen |
| 49288-0575 | Standardized Timothy Grass Pollen | Standardized Timothy Grass Pollen |
| 54575-107 | STANDARDIZED TIMOTHY GRASS POLLEN | Phleum pratense pollen |