NIROGACESTAT HYDROBROMIDE - Food and Drug Administration

Set ID: e50401e8-eee2-4c58-bae9-e0e494a260e4
Type: Indexing - product concept
Effective date: 2023-12-08
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	Product name	SpringWorks Therapeutics, Inc.	2026-09-01
These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	Product name	SpringWorks Therapeutics, Inc.	2026-07-30
These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	Product name	SpringWorks Therapeutics, Inc.	2026-03-26
These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	Product name	SpringWorks Therapeutics, Inc.	2025-10-20
These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	Product name	SpringWorks Therapeutics, Inc.	2024-04-01

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
82448-050	These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	SpringWorks Therapeutics, Inc.
82448-050-18	These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	SpringWorks Therapeutics, Inc.
82448-100	These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	SpringWorks Therapeutics, Inc.
82448-100-14	These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	SpringWorks Therapeutics, Inc.
82448-150	These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	SpringWorks Therapeutics, Inc.
82448-150-14	These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO ® (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023	SpringWorks Therapeutics, Inc.