Omtryg

NDA 204977, held by Osmotica Pharm US. Omega-3-Acid Ethyl Esters Type A.

As of Nov 13, 2026, NDA 204977 (Omtryg), held by Osmotica Pharm US, was first approved by FDA on Apr 23, 2014, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 23, 2014
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 23, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omtryg1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS · capsule;oral	Omega-3-Acid Ethyl Esters Type A	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Jun 20, 2025	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 6, 2017	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 22, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 18, 2016	Supplement 6Manufacturing	Approved	Label
Oct 26, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 2, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 11, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 30, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 23, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 204977
Drugs@FDA: Overview at FDA
Company: Osmotica Pharmaceuticals US

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