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Sucraid
sacrosidase
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Sucraid
Proper name
sacrosidase
Licence type
351(a)
BLA number
020772
Applicant
QOL Medical, LLC
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,003,000IU/118ML (8,500IU/ML) | Solution For Oral | Oral | Bottle | Rx | April 9, 1998 |
| 17,000IU/2ML (8,500IU/ML) | Solution For Oral | Oral | — | Rx | May 25, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 9, 2005 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |