PRALSETINIB - Food and Drug Administration

Set ID: b01d7c5e-8a19-4838-b13a-e7dff83e1be3
Type: Indexing - product concept
Effective date: 2021-05-11
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 GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Product name	Rigel Pharmaceuticals, Inc.	2025-12-30
These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Product name	Rigel Pharmaceuticals, Inc.	2025-12-18
These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Product name	Genentech, Inc.	2025-12-05

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
50242-210	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Genentech, Inc.
50242-210-12	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Genentech, Inc.
50242-210-60	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Genentech, Inc.
50242-210-83	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Genentech, Inc.
50242-210-90	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Genentech, Inc.
71332-006	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Rigel Pharmaceuticals, Inc.
71332-006-12	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Rigel Pharmaceuticals, Inc.
71332-006-60	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Rigel Pharmaceuticals, Inc.
71332-006-90	These highlights do not include all the information needed to use GAVRETO safely and effectively. See full prescribing information for GAVRETO. GAVRETO ® (pralsetinib) capsules, for oral use Initial U.S. Approval: 2020	Rigel Pharmaceuticals, Inc.