APPLICATION
ANDA203893
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-19
LATEST ACTION
2020-10-02
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
2020-10-02Manufacturing (CMC) · Supplement 14AP
2020-10-02Labeling · Supplement 15 · standardAP
2020-03-09Labeling · Supplement 8 · standardAP
2017-09-19UNKNOWN · OriginalAP
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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