← FDA Drug Approvals (Drugs@FDA)

ICOSAPENT ETHYL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2020-05-21

Drug application

FDA Application #

ANDA209457

Application type

Abbreviated New Drug Application (Generic)

Brand name

ICOSAPENT ETHYL

Generic name

ICOSAPENT ETHYL

Active ingredients

ICOSAPENT ETHYL

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Northstar Rx LLC

First approval

2020-05-21

Source

Authoritative

Drugs@FDA application overview

Machine

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