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IRINOTECAN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA FARMACEUTICA · Approved 2010-12-20

Drug application

FDA Application #

ANDA091032

Application type

Abbreviated New Drug Application (Generic)

Brand name

IRINOTECAN HYDROCHLORIDE

Generic name

IRINOTECAN HYDROCHLORIDE

Active ingredients

IRINOTECAN HYDROCHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

HIKMA FARMACEUTICA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2010-12-20

Source

Authoritative

Drugs@FDA application overview

Machine

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