← FDA Drug Approvals (Drugs@FDA)

ICOSAPENT ETHYL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ONESOURCE SPECIALTY · Approved 2023-09-22

Drug application

FDA Application #

ANDA217844

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

ONESOURCE SPECIALTY

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2023-09-22

Source

Authoritative

Drugs@FDA application overview

Machine

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