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FDA NDA · NDA217639

ORSERDU

elacestrant

Sponsor: STEMLINE THERAP

APPLICATION
NDA217639
TYPE
NDA
ORIGINAL APPROVAL
2023-01-27
LATEST ACTION
2026-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ORSERDU · ReferencePrescription
ELACESTRANT HYDROCHLORIDE EQ 86MG BASE · TABLET · ORAL
ORSERDU · ReferencePrescription
ELACESTRANT HYDROCHLORIDE EQ 345MG BASE · TABLET · ORAL

Approval history

2026-06-24Labeling · Supplement 7 · standard — Letter ↗AP
2023-11-09Labeling · Supplement 1 · standard — Letter ↗AP
2023-01-27Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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