APPLICATION
ANDA211345
TYPE
ANDA
ORIGINAL APPROVAL
2023-12-07
LATEST ACTION
2023-12-07
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
2023-12-07UNKNOWN · Original · 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.
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