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FDA NDA · NDA021654

LOVAZA

Sponsor: WAYLIS THERAP

APPLICATION
NDA021654
TYPE
NDA
ORIGINAL APPROVAL
2004-11-10
LATEST ACTION
2020-09-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LOVAZA · ReferencePrescription
OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS · CAPSULE · ORAL

Approval history

2020-09-04Labeling · Supplement 44 · standard — Label ↗AP
2019-04-03Labeling · Supplement 43 · standard — Letter ↗AP
2015-03-09Manufacturing (CMC) · Supplement 42 · standardAP
2014-06-05Manufacturing (CMC) · Supplement 40 · standardAP
2014-05-14Labeling · Supplement 41 · standard — Letter ↗AP
2013-11-15Manufacturing (CMC) · Supplement 38 · standardAP
2013-09-11Manufacturing (CMC) · Supplement 39 · standard — Label ↗AP
2013-06-26Labeling · Supplement 37 · standard — Letter ↗AP
2012-08-31Labeling · Supplement 34 · unknown — Label ↗AP
2011-09-19Labeling · Supplement 33 · unknown — Letter ↗AP
2011-08-11Labeling · Supplement 31 · unknownAP
2010-12-22Labeling · Supplement 30 · unknown — Letter ↗AP
2009-09-16Efficacy · Supplement 22 · standard — Letter ↗AP
2009-04-20Labeling · Supplement 23 · standard — Label ↗AP
2008-06-03Labeling · Supplement 21 · standard — Letter ↗AP
2008-01-24Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP
2007-12-06Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2007-11-07Labeling · Supplement 14 · standard — Patient Information Sheet ↗AP
2007-06-12Labeling · Supplement 16 · standard — Letter ↗AP
2007-02-01Labeling · Supplement 4 · standard — Letter ↗AP
2006-07-03Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2004-11-10Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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