FDA.reportPublic FDA data

ETRAVIRINE - Food and Drug Administration

Set ID
08bcdf9c-0f44-79ee-51ca-e7f77478ea2e
Type
Indexing - Product Concept
Effective date
2023-01-12
Version
2
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
ETRAVIRINE tablets, for oral use These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. Initial U.S. Approval: 2008Product nameAvKARE2026-01-13
These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008Product nameBionpharma Inc. | Recipharm Pharmaservices Private Limited2025-12-18
These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008Product nameAmneal Pharmaceuticals NY LLC2025-09-25
These highlights do not include all the information needed to use Etravirine safely and effectively. See full prescribing information for Etravirine. Etravirine tablets, for oral use Initial U.S. Approval: 2008Product namePatriot Pharmaceuticals | Janssen Pharmaceuticals, Inc | Janssen Pharmaceutica NV | Janssen Cilag SpA | Johnson and Johnson Private Limited2025-04-02
These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008Product nameCarnegie Pharmaceuticals LLC2024-03-05
These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008Product nameLeading Pharma, LLC | Carnegie Pharmaceuticals LLC2024-01-10
These highlights do not include all the information needed to use INTELENCE safely and effectively. See full prescribing information for INTELENCE. INTELENCE ® (etravirine) tablets, for oral use Initial U.S. Approval: 2008Product nameJanssen Products LP | Janssen Pharmaceutica NV | Janssen Cilag SpA | Johnson and Johnson Private Limited | Janssen Pharmaceuticals, Inc | JANSSEN ORTHO LLC2023-08-15
These highlights do not include all the information needed to use ETRAVIRINE TABLETS safely and effectively. See full prescribing information for ETRAVIRINE TABLETS. ETRAVIRINE tablets, for oral use Initial U.S. Approval: 2008Product nameAmneal Pharmaceuticals NY LLC2022-03-30
These highlights do not include all the information needed to use INTELENCE ® safely and effectively. See full prescribing information for INTELENCE ® . INTELENCE ® (etravirine) tablets for oral use Initial U.S. Approval 2008Product namePhysicians Total Care, Inc.2013-01-02
These highlights do not include all the information needed to use INTELENCE ® safely and effectively. See full prescribing information for INTELENCE ® . INTELENCE ® (etravirine) [Tablets] Initial U.S. Approval – 2008Product nameState of Florida DOH Central Pharmacy2010-08-06