← FDA DRUG APPROVALS

FDA BLA · BLA020367

CEREZYME

imiglucerase

Sponsor: GENZYME

APPLICATION
BLA020367
TYPE
BLA
ORIGINAL APPROVAL
1994-05-23
LATEST ACTION
2026-01-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEREZYMEPrescription
IMIGLUCERASE 400 UNITS/VIAL · INJECTABLE · INJECTION
CEREZYMEPrescription
IMIGLUCERASE 200 UNITS/VIAL · INJECTABLE · INJECTION

Approval history

2026-01-12Efficacy · Supplement 123 · standard — Label ↗AP
2024-12-19Labeling · Supplement 122 · standard — Letter ↗AP
2024-07-10Labeling · Supplement 121 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 119 · standard — Letter ↗AP
2016-07-22Manufacturing (CMC) · Supplement 101 · priorityAP
2016-07-07Manufacturing (CMC) · Supplement 99 · priorityAP
2016-06-08Manufacturing (CMC) · Supplement 98 · priorityAP
2016-04-21Manufacturing (CMC) · Supplement 97 · priorityAP
2016-03-03Manufacturing (CMC) · Supplement 96 · priorityAP
2015-10-30Manufacturing (CMC) · Supplement 95 · priorityAP
2015-08-10Manufacturing (CMC) · Supplement 94 · priorityAP
2015-03-09Manufacturing (CMC) · Supplement 92 · priorityAP
2014-09-05Manufacturing (CMC) · Supplement 91 · priorityAP
2014-02-27Manufacturing (CMC) · Supplement 90 · priorityAP
2013-10-30Manufacturing (CMC) · Supplement 89 · priorityAP
2013-07-31Manufacturing (CMC) · Supplement 88 · priorityAP
2005-03-03Manufacturing (CMC) · Supplement 66 — Label ↗AP
2002-11-13Labeling · Supplement 55 · standard — Label ↗AP
2002-10-09Manufacturing (CMC) · Supplement 56 · priorityAP
2002-06-14Labeling · Supplement 53 · standard — Letter ↗AP
2001-08-13Labeling · Supplement 49 · standardAP
2001-08-13Labeling · Supplement 41 · standardAP
2001-08-13Labeling · Supplement 42 · standardAP
2001-05-08Manufacturing (CMC) · Supplement 51 · priorityAP
2001-05-07Manufacturing (CMC) · Supplement 50 · priorityAP
2000-11-14Manufacturing (CMC) · Supplement 48 · priorityAP
2000-10-27Manufacturing (CMC) · Supplement 47 · priorityAP
2000-09-11Manufacturing (CMC) · Supplement 45 · priorityAP
2000-08-31Manufacturing (CMC) · Supplement 46 · priorityAP
2000-07-10Manufacturing (CMC) · Supplement 44 · priorityAP
2000-04-10Manufacturing (CMC) · Supplement 43 · priorityAP
1999-12-08Manufacturing (CMC) · Supplement 40 · priorityAP
1999-10-22Manufacturing (CMC) · Supplement 38 · priorityAP
1999-10-05Manufacturing (CMC) · Supplement 37 · priorityAP
1999-09-22Manufacturing (CMC) · Supplement 34 · priorityAP
1999-09-07Manufacturing (CMC) · Supplement 39 · priorityAP
1999-07-28Manufacturing (CMC) · Supplement 36 · priorityAP
1999-07-26Manufacturing (CMC) · Supplement 35 · priorityAP
1999-02-11Labeling · Supplement 27 · standardAP
1999-01-04Manufacturing (CMC) · Supplement 33 · priorityAP
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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