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FDA BLA · BLA103946

ELITEK

rasburicase

Sponsor: SANOFI SYNTHELABO

APPLICATION
BLA103946
TYPE
BLA
ORIGINAL APPROVAL
2002-07-12
LATEST ACTION
2019-12-12
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ELITEKPrescription
RASBURICASE 1.5MG/VIAL · VIAL · INTRAVENOUS

Approval history

2019-12-12Labeling · Supplement 5103 · standard — Letter ↗AP
2017-09-14Labeling · Supplement 5101 · standard — Label ↗AP
2016-06-13Labeling · Supplement 5097 · standard — Label ↗AP
2015-05-22Labeling · Supplement 5095 · standard — Label ↗AP
2015-02-03Labeling · Supplement 5094 · standard — Letter ↗AP
2009-10-16Efficacy · Supplement 5083 · standard — Label ↗AP
2007-09-10Labeling · Supplement 5049 · standard — Label ↗AP
2007-09-10Supplement · Supplement 5039AP
2007-02-28Labeling · Supplement 5047 · standardAP
2004-12-15Labeling · Supplement 5017 · standard — Label ↗AP
2002-07-12Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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