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FDA BLA · BLA125141

MYOZYME

Sponsor: GENZYME

APPLICATION
BLA125141
TYPE
BLA
ORIGINAL APPROVAL
2006-04-28
LATEST ACTION
2020-02-18
ROUTE
IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MYOZYMEPrescription
ALGLUCOSIDASE ALFA 20MG/KG · INJECTABLE · IV (INFUSION)

Approval history

2020-02-18Labeling · Supplement 223 · standard — Label ↗AP
2019-05-30Labeling · Supplement 222 · standard — Label ↗AP
2014-05-20Labeling · Supplement 219 · standard — Label ↗AP
2012-07-09Labeling · Supplement 176 · standard — Label ↗AP
2010-06-11Labeling · Supplement 116 · standardAP
2008-12-08Labeling · Supplement 74 · standard — Label ↗AP
2006-04-28Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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