APPLICATION
ANDA091028
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-07
LATEST ACTION
2021-01-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OMEGA-3-ACID ETHYL ESTERSPrescription
OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS · CAPSULE · ORAL
Approval history
2021-01-06Labeling · Supplement 6 · standardAP
2020-04-02Labeling · Supplement 5 · standardAP
2014-06-25Labeling · Supplement 1 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.