FDA NDA · NDA204977

OMTRYG

Sponsor: OSMOTICA PHARM US

APPLICATION

NDA204977

TYPE

NDA

ORIGINAL APPROVAL

2014-04-23

LATEST ACTION

2025-06-20

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Discontinued

Products

OMTRYG · ReferenceDiscontinued

OMEGA-3-ACID ETHYL ESTERS TYPE A 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS · CAPSULE · ORAL

2025-06-20Labeling · Supplement 10 · standard — Label ↗AP

2017-01-06Manufacturing (CMC) · Supplement 9 · standardAP

2016-07-22Manufacturing (CMC) · Supplement 7 · standardAP

2016-03-18Manufacturing (CMC) · Supplement 6 — Label ↗AP

2015-10-26Manufacturing (CMC) · Supplement 5 · standardAP

2015-09-02Manufacturing (CMC) · Supplement 4 · standardAP

2014-11-11Manufacturing (CMC) · Supplement 2 · standardAP

2014-10-30Manufacturing (CMC) · Supplement 1 · standardAP

2014-04-23Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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