Product NDC: | 58468-0150 |
Proprietary Name: | Myozyme |
Non Proprietary Name: | ALGLUCOSIDASE ALFA |
Active Ingredient(s): | 5 mg/mL & nbsp; ALGLUCOSIDASE ALFA |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-0150 |
Labeler Name: | Genzyme Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125141 |
Marketing Category: | BLA |
Start Marketing Date: | 20100619 |
Package NDC: | 58468-0150-1 |
Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (58468-0150-1) > 10.5 mL in 1 VIAL, SINGLE-USE |
NDC Code | 58468-0150-1 |
Proprietary Name | Myozyme |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (58468-0150-1) > 10.5 mL in 1 VIAL, SINGLE-USE |
Product NDC | 58468-0150 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ALGLUCOSIDASE ALFA |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20100619 |
Marketing Category Name | BLA |
Labeler Name | Genzyme Corporation |
Substance Name | ALGLUCOSIDASE ALFA |
Strength Number | 5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC] |