STANDARDIZED MITE D PTERONYSSINUS is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Allergy Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus.
| Product ID | 54575-326_27179a6a-453e-4e7d-8115-f98dcfcf3ec5 |
| NDC | 54575-326 |
| Product Type | Standardized Allergenic |
| Proprietary Name | STANDARDIZED MITE D PTERONYSSINUS |
| Generic Name | Dermatophagoides Pteronyssinus |
| Dosage Form | Injection, Solution |
| Route of Administration | PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 1991-12-11 |
| Marketing Category | BLA / BLA |
| Application Number | BLA101378 |
| Labeler Name | Allergy Laboratories, Inc. |
| Substance Name | DERMATOPHAGOIDES PTERONYSSINUS |
| Active Ingredient Strength | 10000 [AU]/mL |
| Pharm Classes | Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 1991-12-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA101378 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1991-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | BLA |
| Application Number | BLA101378 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1991-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | BLA |
| Application Number | BLA101378 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1991-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | BLA |
| Application Number | BLA101378 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1991-12-11 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| DERMATOPHAGOIDES PTERONYSSINUS | 10000 [AU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 54575-326 | STANDARDIZED MITE D PTERONYSSINUS | Dermatophagoides pteronyssinus |
| 22840-0035 | Standardized Mite Dermatophagoides pteronyssinus | Dermatophagoides pteronyssinus |
| 22840-0036 | Standardized Mite Dermatophagoides pteronyssinus | Dermatophagoides pteronyssinus |
| 22840-0039 | Standardized Mite Dermatophagoides pteronyssinus | Dermatophagoides pteronyssinus |