FDA.reportPublic FDA data

TAPENTADOL HYDROCHLORIDE - Food and Drug Administration

Set ID
279f6ab2-ad0d-a4be-abc3-377fa3441fa2
Type
Indexing - Product Concept
Effective date
2014-05-08
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use Tapentadol extended-release tablets safely and effectively. See full prescribing information for tapentadol extended-release tablet Tapentadol extended-release tablet for oral use C-II Initial U.S. Approval: 2008Product nameHikma Pharmaceuticals USA Inc. | Collegium Pharmaceutical, Inc.2026-02-26
These highlights do not include all the information needed to use TAPENTADOL TABLETS safely and effectively. See full prescribing information for TAPENTADOL TABLETS. Tapentadol tablets for oral use C-II Initial U.S. Approval: 2008Product nameHikma Pharmaceuticals USA Inc. | Collegium Pharmaceutical, Inc.2026-02-26
These highlights do not include all the information needed to use TAPENTADOL TABLETS safely and effectively. See full prescribing information for TAPENTADOL TABLETS. TAPENTADOL tablets, for oral use CII Initial U.S. Approval: 2008Product nameEPIC PHARMA LLC | Humanwell Pharmaceutical US, Inc2026-01-28
These highlights do not include all the information needed to use NUCYNTA ® ER safely and effectively. See full prescribing information for NUCYNTA ® ER NUCYNTA ® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008Product nameCollegium Pharmaceutical, Inc. | Janssen Pharmaceuticals, Inc. | Janssen Ortho, LLC | Patheon Pharmaceuticals, Inc.2025-12-30
These highlights do not include all the information needed to use NUCYNTA ® TABLETS safely and effectively. See full prescribing information for NUCYNTA ® TABLETS. NUCYNTA ® (tapentadol) tablets for oral use C-II Initial U.S. Approval: 2008Product nameCollegium Pharmaceutical, Inc. | Janssen Pharmaceuticals, Inc. | Halo Pharmaceutical, Inc. d/b/a Cambrex2025-12-30
Risk Evaluation and Mitigation Strategy (REMS) Document Opioid Analgesic Shared System REMSProduct nameSyneos Health2024-10-31
These highlights do not include all the information needed to use NUCYNTA ® TABLETS safely and effectively. See full prescribing information for NUCYNTA ® TABLETS. NUCYNTA ® (tapentadol) tablets for oral use C-II Initial U.S. Approval: 2008Product nameDepo NF Sub, LLC | Janssen Pharmaceuticals, Inc. | Janssen Ortho, LLC2018-12-07
These highlights do not include all the information needed to use NUCYNTA ® ER safely and effectively. See full prescribing information for NUCYNTA ® ER NUCYNTA ® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008Product nameDepo NF Sub, LLC | Janssen Pharmaceuticals, Inc. | Janssen Ortho, LLC2018-10-22
These highlights do not include all the information needed to use NUCYNTA ® safely and effectively. See full prescribing information for NUCYNTA ® . NUCYNTA ® (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 2008Product nameRebel Distributors Corp2011-07-29
These highlights do not include all the information needed to use NUCYNTA ® safely and effectively. See full prescribing information for NUCYNTA ® . NUCYNTA ® (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 2008Product nameSTAT RX USA LLC2010-07-09
These highlights do not include all the information needed to use NUCYNTA® safely and effectively. See full prescribing information for NUCYNTA®. NUCYNTA® (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 2008Product namePhysicians Total Care, Inc.2010-03-24
These highlights do not include all the information needed to use NUCYNTA™ safely and effectively. See full prescribing information for NUCYNTA™. NUCYNTA™ (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 2008Product nameStat Rx USA2009-10-27