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ORSERDU

NDA · New Drug Application · Sponsor: STEMLINE THERAP · Approved 2023-01-27

Drug application

FDA Application #

NDA217639

Application type

New Drug Application

Brand name

ORSERDU

Generic name

ELACESTRANT

Active ingredients

ELACESTRANT HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

STEMLINE THERAP

Manufacturer

Stemline Therapeutics, Inc.

First approval

2023-01-27

Source

Authoritative

Drugs@FDA application overview

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