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FDA NDA · NDA021711

ABLAVAR

Sponsor: LANTHEUS MEDCL

APPLICATION
NDA021711
TYPE
NDA
ORIGINAL APPROVAL
2008-12-22
LATEST ACTION
2013-08-07
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ABLAVARDiscontinued
GADOFOSVESET TRISODIUM 3660MG/15ML (244MG/ML) · SOLUTION · INTRAVENOUS
ABLAVARDiscontinued
GADOFOSVESET TRISODIUM 2440MG/10ML (244MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2013-08-07Labeling · Supplement 4 · standard — Letter ↗AP
2010-12-20Labeling · Supplement 3 · unknown — Label ↗AP
2010-01-11Labeling · Supplement 1 · standard — Letter ↗AP
2008-12-22Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
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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