NDC Code: |
58468-0040 |
Proprietary Name: |
Fabrazyme |
Suffix: |
|
Non-Proprietary Name: |
AGALSIDASE BETA |
Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
17-12-2008 |
Category Name: |
BLA |
Application Number: |
BLA103979 |
Labeler: |
GENZYME CORPORATION |
Substance Name: |
AGALSIDASE BETA |
Active Numerator Strength: |
5 |
Active Ingredient Unit: |
mg/mL |
Pharm Classes: |
alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] |
DEA Schedule: |
|