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FDA NDA · NDA205060

EPANOVA

Sponsor: ASTRAZENECA

APPLICATION
NDA205060
TYPE
NDA
ORIGINAL APPROVAL
2014-05-05
LATEST ACTION
2017-03-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

EPANOVA · ReferenceDiscontinued
OMEGA-3-CARBOXYLIC ACIDS 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS · CAPSULE · ORAL

Approval history

2017-03-09Labeling · Supplement 3 · standard — Label ↗AP
2017-03-09Labeling · Supplement 6 · standardAP
2016-12-30Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2016-10-07Labeling · Supplement 2 · standard — Letter ↗AP
2016-05-27Manufacturing (CMC) · Supplement 1 · standardAP
2014-05-05Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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