Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217639
Company: STEMLINE THERAP

Products on NDA 217639

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORSERDU	ELACESTRANT HYDROCHLORIDE	EQ 86MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ORSERDU	ELACESTRANT HYDROCHLORIDE	EQ 345MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217639

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217639Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217639Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217639Orig1s001ltr.pdf

Labels for NDA 217639

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2023	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf
11/09/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf
01/27/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s000correctedlbl.pdf