← FDA Drug Approvals (Drugs@FDA)

FULVESTRANT

NDA · New Drug Application · Sponsor: FRESENIUS KABI USA · Approved 2019-05-20

Drug application

FDA Application #

NDA210326

Application type

New Drug Application

Brand name

FULVESTRANT

Generic name

FULVESTRANT

Active ingredients

FULVESTRANT

Dosage form

SOLUTION

Route

INTRAMUSCULAR

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2019-05-20

Source

Authoritative

Drugs@FDA application overview

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