FDA.reportPublic FDA data

GUSELKUMAB - Food and Drug Administration

Set ID
32f71a4d-ecdf-47e6-a4d4-be46f5f415dd
Type
Indexing - product concept
Effective date
2025-03-25
Version
2
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA ® (guselkumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2017Product nameJanssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica, NV | Jannsen Biologics B.V. | Cilag AG | Biogen MA, Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC2026-06-04
These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA ® (guselkumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2017Product nameJanssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica NV | Janssen Biologics B.V. | Cilag AG | Biogen MA Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC2025-10-27
These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA ® (guselkumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2017Product nameJanssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica NV | Janssen Biologics B.V. | Cilag AG | Biogen MA Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC2025-09-29
These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA ® (guselkumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2017Product nameJanssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica, NV | Jannsen Biologics B.V. | Cilag AG | Biogen MA, Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC2025-09-29
These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA ® (guselkumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2017Product nameJanssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica NV | Janssen Biologics B.V. | Cilag AG | Biogen MA Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC2025-08-25