FDA.reportPublic FDA data

OXYMORPHONE HYDROCHLORIDE - Food and Drug Administration

Set ID
0476a93f-c9eb-691e-8ebf-e5b816d8f47b
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 oxymorphone hydrochloride safely and effectively. See full prescribing information for oxymorphone hydrochloride tablets. OXYMORPHONE HYDROCHLORIDE TABLETS, for oral use CII Initial U.S. Approval: 1959Product nameAurolife Pharma, LLC2026-06-29
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS. OXYMORPHONE HYDROCHLORIDE tablets for oral use CII Initial U.S. Approval: 1959Product nameKVK-Tech, Inc. | KVK-TECH, INC | KVK-TECH,Inc.2026-01-30
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959Product nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC2026-01-15
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS USP safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS USP . OXYMORPHONE hydrochloride tablets USP, for oral use, CII Initial U.S. Approval: 1959Product nameEpic Pharma, LLC2025-12-15
These highlights do not include all the information needed to use Oxymorphone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxymorphone Hydrochloride Tablets. OXYMORPHONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1959Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2025-12-12
These highlights do not include all the information needed to use oxymorphone hydrochloride safely and effectively. See full prescribing information for oxymorphone hydrochloride tablets. OXYMORPHONE HYDROCHLORIDE TABLETS, for oral use CII Initial U.S. Approval: 1959Product nameAurolife Pharma, LLC2025-12-02
These highlights do not include all the information needed to use Oxymorphone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxymorphone Hydrochloride Tablets. OXYMORPHONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1959Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2025-10-21
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS. OXYMORPHONE HYDROCHLORIDE tablets, for Oral use CII Initial U.S. Approval: 1959Product nameCamber Pharmaceuticals, Inc | Ascent Pharmaceuticals, Inc2025-08-18
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 OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1959Product nameAmneal Pharmaceuticals of New York LLC2024-01-10
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS. OXYMORPHONE HYDROCHLORIDE tablets, for Oral use CII Initial U.S. Approval: 1959Product nameBryant Ranch Prepack2024-01-09
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS. OXYMORPHONE HYDROCHLORIDE tablets, for Oral use CII Initial U.S. Approval: 1959Product nameXLCare Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc2020-05-07
These highlights do not include all the information needed to use OXYMORPHONE hydrochloride Extended-Release Tablets safely and effectively. See full prescribing information for OXYMORPHONE hydrochloride Extended-Release Tablets. OXYMORPHONE hydrochloride Extended-Release Tablets, for oral use, CII Initial U.S. Approval: 1959Product nameRanbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc._Terminal2016-09-13
These highlights do not include all the information needed to use Oxymorphone Hydrochloride Tablets safely and effectively. See full prescribing information for Oxymorphone Hydrochloride Tablets, CII. Initial U.S. Approval: 1959Product namePhysicians Total Care, Inc.2013-01-02
These highlights do not include all the information needed to use OPANA safely and effectively. See full prescribing information for OPANA. OPANA (oxymorphone hydrochloride) tablets, CII Initial U.S. Approval: 1959Product nameSTAT Rx USA LLC2012-01-13
STAT RX USA LLC human prescription drug labelProduct nameSTAT RX USA LLC2011-07-15
OPANA ® ER (Oxymorphone Hydrochloride) Extended-Release Tablets 5mg, 10mg, 20mg, and 40mg CII Rx OnlyProduct nameRebel Distributors Corp2011-05-31