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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217677
Company: SPRINGWORKS

Products on NDA 217677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OGSIVEO	NIROGACESTAT HYDROBROMIDE	EQ 50MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
OGSIVEO	NIROGACESTAT HYDROBROMIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	No
OGSIVEO	NIROGACESTAT HYDROBROMIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217677Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217677Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2026	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217677s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217677Orig1s006ltr.pdf
04/04/2024	SUPPL-1	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217677Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217677Orig1s001ltr.pdf

Labels for NDA 217677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2026	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217677s006lbl.pdf
04/04/2024	SUPPL-1	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217677Orig1s001lbl.pdf
11/27/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf

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