← FDA Drug Approvals (Drugs@FDA)

ICOSAPENT ETHYL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2026-06-24

Drug application

FDA Application #

ANDA218949

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

AUROBINDO PHARMA LTD

Manufacturer

Aurobindo Pharma Limited

First approval

2026-06-24

Source

Authoritative

Drugs@FDA application overview

Machine

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