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FDA BLA · BLA020772

SUCRAID

sacrosidase

Sponsor: QOL MEDCL

APPLICATION
BLA020772
TYPE
BLA
ORIGINAL APPROVAL
1998-04-09
LATEST ACTION
2024-08-02
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SUCRAIDPrescription
SACROSIDASE 8,500 IU/ML · SOLUTION · ORAL

Approval history

2024-08-02Labeling · Supplement 31 · standard — Letter ↗AP
2024-07-24Labeling · Supplement 30 · standard — Letter ↗AP
2022-05-25Manufacturing (CMC) · Supplement 27 — Label ↗AP
2015-09-21Manufacturing (CMC) · Supplement 20 · priorityAP
2015-02-16Manufacturing (CMC) · Supplement 19 · priorityAP
2014-12-02Manufacturing (CMC) · Supplement 17 · priorityAP
2014-11-07Manufacturing (CMC) · Supplement 15 · priorityAP
2013-05-28Manufacturing (CMC) · Supplement 13 · priorityAP
2011-06-15Labeling · Supplement 8 · standard — Letter ↗AP
2010-12-09REMS · Supplement 11 — Letter ↗AP
2008-11-20Manufacturing (CMC) · Supplement 6AP
2008-11-20Manufacturing (CMC) · Supplement 7 · priorityAP
2008-11-20Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2008-02-20Manufacturing (CMC) · Supplement 4AP
2006-11-03Manufacturing (CMC) · Supplement 2 — Letter ↗AP
1998-04-09Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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