Product NDC: | 58468-0041 |
Proprietary Name: | Fabrazyme |
Non Proprietary Name: | AGALSIDASE BETA |
Active Ingredient(s): | 5 mg/mL & nbsp; AGALSIDASE BETA |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-0041 |
Labeler Name: | Genzyme Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA103979 |
Marketing Category: | BLA |
Start Marketing Date: | 20081217 |
Package NDC: | 58468-0041-1 |
Package Description: | 1 mL in 1 VIAL, GLASS (58468-0041-1) |
NDC Code | 58468-0041-1 |
Proprietary Name | Fabrazyme |
Package Description | 1 mL in 1 VIAL, GLASS (58468-0041-1) |
Product NDC | 58468-0041 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | AGALSIDASE BETA |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20081217 |
Marketing Category Name | BLA |
Labeler Name | Genzyme Corporation |
Substance Name | AGALSIDASE BETA |
Strength Number | 5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] |