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AVGEMSI

NDA · New Drug Application · Sponsor: AVYXA HOLDINGS · Approved 2025-06-27

Drug application

FDA Application #

NDA219920

Application type

New Drug Application

Brand name

AVGEMSI

Generic name

GEMCITABINE

Active ingredients

GEMCITABINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

AVYXA HOLDINGS

Manufacturer

Avyxa Pharma, LLC

First approval

2025-06-27

Source

Authoritative

Drugs@FDA application overview

Machine

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