Product NDC: | 65044-6691 |
Proprietary Name: | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
Non Proprietary Name: | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
Active Ingredient(s): | 5000; 5000 [AU]/mL; [AU]/mL & nbsp; Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
Administration Route(s): | SUBCUTANEOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 65044-6691 |
Labeler Name: | Jubilant HollisterStier LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA103870 |
Marketing Category: | BLA |
Start Marketing Date: | 19880526 |
Package NDC: | 65044-6691-4 |
Package Description: | 50 mL in 1 VIAL (65044-6691-4) |
NDC Code | 65044-6691-4 |
Proprietary Name | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
Package Description | 50 mL in 1 VIAL (65044-6691-4) |
Product NDC | 65044-6691 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | SUBCUTANEOUS |
Start Marketing Date | 19880526 |
Marketing Category Name | BLA |
Labeler Name | Jubilant HollisterStier LLC |
Substance Name | DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS |
Strength Number | 5000; 5000 |
Strength Unit | [AU]/mL; [AU]/mL |
Pharmaceutical Classes | Standardized Insect Protein Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Protein Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] |