Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Dermatophagoides Pteronyssinus.
| Product ID | 65044-6695_48ff8f81-67b4-4649-83e6-20002d4a02b8 |
| NDC | 65044-6695 |
| Product Type | Standardized Allergenic |
| Proprietary Name | Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL |
| Generic Name | Standardized Mite, Dermatophagoides Pteronyssinus, Bulk, 10000 Au Per Ml |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 1988-05-26 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103871 |
| Labeler Name | Jubilant HollisterStier LLC |
| 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 | N |
| Listing Certified Through | 2021-12-31 |