← FDA DRUG APPROVALS

FDA NDA · NDA202057

VASCEPA

icosapent ethyl

Sponsor: AMARIN PHARMS

APPLICATION
NDA202057
TYPE
NDA
ORIGINAL APPROVAL
2012-07-26
LATEST ACTION
2019-12-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VASCEPA · ReferencePrescription
ICOSAPENT ETHYL 500MG · CAPSULE · ORAL
VASCEPA · ReferencePrescription
ICOSAPENT ETHYL 1GM · CAPSULE · ORAL

Approval history

2019-12-13Efficacy · Supplement 35 · priority — Label ↗AP
2017-02-16Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2016-01-28Manufacturing (CMC) · Supplement 15 · standardAP
2016-01-25Manufacturing (CMC) · Supplement 16 · standardAP
2015-10-02Manufacturing (CMC) · Supplement 14 · standardAP
2015-08-04Manufacturing (CMC) · Supplement 13 · standardAP
2015-06-23Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2014-10-16Manufacturing (CMC) · Supplement 11 · standardAP
2014-08-14Manufacturing (CMC) · Supplement 10 · standardAP
2014-07-28Manufacturing (CMC) · Supplement 7 · standardAP
2014-02-26Manufacturing (CMC) · Supplement 8 · standardAP
2014-02-13Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2013-11-25Labeling · Supplement 9 · standard — Label ↗AP
2013-04-19Manufacturing (CMC) · Supplement 4 · standardAP
2013-04-12Manufacturing (CMC) · Supplement 3 · standardAP
2013-03-20Manufacturing (CMC) · Supplement 2 — Label ↗AP
2013-01-31Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2012-07-26Type 5 - New Formulation or New Manufacturer · Original · standard — 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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