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Cerezyme
imiglucerase
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Cerezyme
Proper name
imiglucerase
Licence type
351(a)
BLA number
020367
Applicant
Genzyme Corporation
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Disc | May 23, 1994 |
| 400UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Rx | September 22, 1999 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 23, 2001 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |