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FDA BLA · BLA103770

SYNAGIS

palivizumab

Sponsor: SWEDISH ORPHAN

APPLICATION
BLA103770
TYPE
BLA
ORIGINAL APPROVAL
1998-06-19
LATEST ACTION
2017-05-12
ROUTE
INTRAMUSCULAR
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

SYNAGISPrescription
PALIVIZUMAB 100MG/VIAL · VIAL
SYNAGISPrescription
PALIVIZUMAB 50MG/VIAL · VIAL

Approval history

2017-05-12Labeling · Supplement 5200 · standard — Label ↗AP
2014-03-21Labeling · Supplement 5185 · standard — Label ↗AP
2012-04-04Efficacy · Supplement 5161 · standard — Letter ↗AP
2011-04-04Labeling · Supplement 5153 · standard — Letter ↗AP
2009-03-23Labeling · Supplement 5116 · standard — Letter ↗AP
2008-08-01Labeling · Supplement 5113 · standard — Letter ↗AP
2007-02-28Labeling · Supplement 5096 · standard — Label ↗AP
2004-07-23Supplement · Supplement 5059 — Label ↗AP
2003-09-15Efficacy · Supplement 5033 · standard — Review ↗AP
2002-10-23Supplement · Supplement 5022 — Label ↗AP
1998-06-19Type 1 - New Molecular Entity · Original · priority — Review ↗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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