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OMEGA-3-ACID ETHYL ESTERS

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOFGEN PHARMS · Approved 2019-07-10

Drug application

FDA Application #

ANDA211355

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEGA-3-ACID ETHYL ESTERS

Generic name

OMEGA-3-ACID ETHYL ESTERS

Active ingredients

OMEGA-3-ACID ETHYL ESTERS

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

SOFGEN PHARMS

Manufacturer

Chartwell RX, LLC

First approval

2019-07-10

Source

Authoritative

Drugs@FDA application overview

Machine

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