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ONGENTYS

NDA · New Drug Application · Sponsor: AMNEAL · Approved 2020-04-24

Drug application

FDA Application #

NDA212489

Application type

New Drug Application

Brand name

ONGENTYS

Generic name

OPICAPONE

Active ingredients

OPICAPONE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2020-04-24

Source

Authoritative

Drugs@FDA application overview

Machine

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