Standardized Mite, Mixed is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Dermatophagoides Farinae; Dermatophagoides Pteronyssinus.
| Product ID | 0268-7003_0d272bb1-4853-4bef-a694-5aef113225e6 |
| NDC | 0268-7003 |
| Product Type | Standardized Allergenic |
| Proprietary Name | Standardized Mite, Mixed |
| Generic Name | Standardized Mite, Mixed |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1991-07-08 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103060 |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS |
| Active Ingredient Strength | 5000 [AU]/mL; [AU]/mL |
| Pharm Classes | Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],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 | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 1991-07-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA103060 |
| Product Type | STANDARDIZED ALLERGENIC |
| Marketing Start Date | 1991-07-08 |
| Ingredient | Strength |
|---|---|
| DERMATOPHAGOIDES FARINAE | 5000 [AU]/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-7002 | Standardized Mite, Mixed | Standardized Mite, Mixed |
| 0268-7003 | Standardized Mite, Mixed | Standardized Mite, Mixed |
| 0268-8116 | STANDARDIZED MITE, MIXED | DERMATOPHAGOIDES FARINAE and DERMATOPHAGOIDES PTERONYSSINUS |