ELRANATAMAB - Food and Drug Administration

Set ID: bf04f12d-3435-41d4-973b-e759446596f3
Type: Indexing - product concept
Effective date: 2024-10-08
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 ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Product name	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.	2026-09-14
These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Product name	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC	2026-05-14
These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Product name	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.	2026-02-26
These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Product name	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.	2026-02-26
Risk Evaluation and Mitigation Strategy (REMS) Document ELREXFIO (elranatamab-bcmm) REMS	Product name	Pfizer Inc.	2025-07-10

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
0069-2522	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
0069-2522-01	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
0069-2522-02	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
0069-4494	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
0069-4494-01	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
0069-4494-02	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
63539-252	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
63539-252	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC
63539-252-01	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
63539-252-01	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC
63539-252-02	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC \| PPD Development, L.P.
63539-252-02	These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023	U.S. Pharmaceuticals \| Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC