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ONIVYDE

NDA · New Drug Application · Sponsor: IPSEN · Approved 2015-10-22

Drug application

FDA Application #

NDA207793

Application type

New Drug Application

Brand name

ONIVYDE

Generic name

IRINOTECAN HYDROCHLORIDE

Active ingredients

IRINOTECAN HYDROCHLORIDE

Dosage form

INJECTABLE, LIPOSOMAL

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

IPSEN

Manufacturer

Ipsen Biopharmaceuticals, Inc.

First approval

2015-10-22

Source

Authoritative

Drugs@FDA application overview

Machine

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