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FDA ANDA · ANDA206455

OMEGA-3-ACID ETHYL ESTER

omega-3-acid ethyl esters

Sponsor: CHARTWELL

APPLICATION
ANDA206455
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-07
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 3 · standardAP
2019-08-07UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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