FDA.reportPublic FDA data

CABOTEGRAVIR - Food and Drug Administration

Set ID
f306ec07-0d7d-45ce-ade0-e6c8659560b1
Type
Indexing - product concept
Effective date
2021-06-21
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EMTRICITABINE, RILPIVIRINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2011Product nameLaurus Labs Limited | Laurus Labs Limited (VSP2)2026-03-05
These highlights do not include all the information needed to use RILPIVIRINE TABLETS safely and effectively. See full prescribing information for RILPIVIRINE TABLETS RILPIVIRINE tablets, for oral use Initial U.S. Approval:2011Product nameSomerset Therapeutics, LLC | Piramal Pharma Limited2026-02-05
These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016Product nameGilead Sciences, Inc.2025-12-02
These highlights do not include all the information needed to use CABENUVA safely and effectively. See full prescribing information for CABENUVA. CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use Initial U.S. Approval: 2021Product nameViiV Healthcare Company | Glaxo Wellcome Manufacturing Pte. Ltd | Janssen Pharmaceutica NV2025-11-26
These highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA. JULUCA (dolutegravir and rilpivirine tablets), for oral use Initial U.S. Approval: 2017Product nameViiV Healthcare Company2025-10-29
These highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA. JULUCA (dolutegravir and rilpivirine tablets), for oral use Initial U.S. Approval: 2017Product nameViiV Healthcare Company2025-10-29
These highlights do not include all the information needed to use EDURANT safely and effectively. See full prescribing information for EDURANT. EDURANT ® (rilpivirine) tablets, for oral use EDURANT ® PED (rilpivirine) tablets, for oral suspension Initial U.S. Approval: 2011Product nameJanssen Products, LP | AndersonBrecon Inc | Janssen Pharmaceutica NV | Janssen-Cilag SpA | Johnson & Johnson Private Limited | Janssen Pharmaceutical Sciences Unlimited Company2025-08-28
These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA ® (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011Product nameGilead Sciences, Inc.2025-07-16
These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011Product nameGilead Sciences, Inc.2025-07-16
These highlights do not include all the information needed to use APRETUDE safely and effectively. See full prescribing information for APRETUDE. APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use Initial U.S. Approval: 2021Product nameViiV Healthcare Company2025-04-11
These highlights do not include all the information needed to use VOCABRIA safely and effectively. See full prescribing information for VOCABRIA. VOCABRIA (cabotegravir) tablets, for oral use Initial U.S. Approval: 2021Product nameViiV Healthcare Company2025-04-11
These highlights do not include all the information needed to use EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EMTRICITABINE, RILPIVIRINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2011Product nameMylan Pharmaceuticals Inc.2024-12-14
These highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA. JULUCA (dolutegravir and rilpivirine tablets), for oral use Initial U.S. Approval: 2017Product nameViiV Healthcare Company2024-04-18
These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016Product nameA-S Medication Solutions2018-01-10
These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011Product namePhysicians Total Care, Inc.2013-03-15