← FDA Drug Approvals (Drugs@FDA)

ICOSAPENT ETHYL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HUMANWELL PURACAP · Approved 2023-12-22

Drug application

FDA Application #

ANDA217919

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

HUMANWELL PURACAP

Manufacturer

EPIC PHARMA, LLC

First approval

2023-12-22

Source

Authoritative

Drugs@FDA application overview

Machine

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