Epanova

NDA 205060, held by Astrazeneca. Omega-3-Carboxylic Acids.

As of Nov 15, 2026, NDA 205060 (Epanova), held by Astrazeneca, was first approved by FDA on May 5, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: May 5, 2014
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 5, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Epanova1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS · capsule;oral	Omega-3-Carboxylic Acids	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Mar 9, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Mar 9, 2017	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 30, 2016	Supplement 4Manufacturing	Approved	Letter
Oct 7, 2016	Supplement 2Labeling · Standard review	Approved	Letter Label
May 27, 2016	Supplement 1Manufacturing · Standard review	Approved	None posted
May 5, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 205060
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters