Product Details for: Fabrazyme Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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| Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
|---|---|---|---|---|---|---|---|
| 001 | For Injection | Intravenous | 35MG | Single-Dose Vial | 351(a) | Fabrazyme | Rx |
| 002 | For Injection | Intravenous | 5MG | Single-Dose Vial | 351(a) | Fabrazyme | Rx |
Proper Name
agalsidase beta
BLA Number
103979
Applicant
Genzyme Corporation
Original Approval Date
April 24, 2003
Date of First Licensure