FDA BLA · BLA125058

ALDURAZYME

laronidase

Sponsor: BIOMARIN

APPLICATION

BLA125058

TYPE

BLA

ORIGINAL APPROVAL

2003-04-30

LATEST ACTION

2023-12-14

ROUTE

INTRAVENOUS

DOSAGE FORM

VIAL

MARKETING STATUS

Prescription

Products

ALDURAZYMEPrescription

LARONIDASE 2.9MG/ML · VIAL

2023-12-14Labeling · Supplement 246 · standard — Label ↗AP

2019-12-04Labeling · Supplement 244 · standard — Letter ↗AP

2013-04-03Labeling · Supplement 220 · standard — Letter ↗AP

2011-07-13Labeling · Supplement 209 · standardAP

2010-05-14Labeling · Supplement 186 · standard — Label ↗AP

2009-08-25Labeling · Supplement 158 · standardAP

2009-05-20Efficacy · Supplement 161 · standard — Letter ↗AP

2009-05-20Efficacy · Supplement 160 · standard — Label ↗AP

2008-04-14Labeling · Supplement 154 · standard — Letter ↗AP

2003-04-30Type 1 - New Molecular Entity · Original · priority — Review ↗AP

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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