FDA.reportPublic FDA data

HYDROXYUREA - Food and Drug Administration

Set ID
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7
Type
Indexing - product concept
Effective date
2025-01-29
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameMajor Pharmaceuticals2026-05-27
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product namePar Health USA, LLC2026-05-07
Yunigen, Inc. human prescription drug labelProduct nameYunigen, Inc.2026-04-06
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameAmerican Health Packaging2026-03-02
These highlights do not include all the information needed to use XROMI safely and effectively. See full prescribing information for XROMI. XROMI (hydroxyurea) oral solution Initial U.S. Approval: 1967Product nameNova Laboratories, Ltd. | Rare Disease Therapeutics, Inc. | Nova Laboratories, Ltd2026-02-02
These highlights do not include all the information needed to use XROMI safely and effectively. See full prescribing information for XROMI. XROMI (hydroxyurea) oral solution Initial U.S. Approval: 1967Product nameNova Laboratories, Ltd. | Rare Disease Therapeutics, Inc. | Nova Laboratories, Ltd2026-02-02
These highlights do not include all the information needed to use DROXIA safely and effectively. See full prescribing information for DROXIA. DROXIA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967Product nameH2-Pharma LLC | CHEPLAPHARM Arzneimittel GmbH2026-01-26
These highlights do not include all the information needed to use HYDREA safely and effectively. See full prescribing information for HYDREA. HYDREA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967Product nameH2-Pharma LLC | CHEPLAPHARM Arzneimittel GmbH2026-01-26
These highlights do not include all the information needed to use SIKLOS safely and effectively. See full prescribing information for SIKLOS. SIKLOS (hydroxyurea) tablets, for oral use Initial U.S. Approval: 1967Product nameMedunik | Addmedica2026-01-07
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameCoupler LLC | Qilu Pharmaceutical Co., Ltd.2025-12-02
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameMajor Pharmaceuticals2025-11-18
Hydroxyurea Capsules USP Rx Only These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameAvKARE2025-10-15
These highlights do not include all the information needed to use HYDREA safely and effectively. See full prescribing information for HYDREA. HYDREA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967Product nameWaylis Therapeutics LLC | Latina Pharma SpA2025-09-15
These highlights do not include all the information needed to use DROXIA safely and effectively. See full prescribing information for DROXIA. DROXIA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967Product nameWaylis Therapeutics LLC | Latina Pharma SpA2025-09-12
Hydroxyurea Capsules USP Rx Only These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameAvKARE2025-09-05
HYDROXYUREA CAPSULES. These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967.Product nameGolden State Medical Supply, Inc.2024-11-25
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967.Product nameLeading Pharma, LLC | Halo Pharmaceutical Inc2024-10-29
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameSomerset Therapeutics, LLC | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)2024-09-23
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameTeva Pharmaceuticals USA, Inc.2024-05-30
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967Product nameQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)2024-04-30
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967.Product nameMarlex Pharmaceuticals, Inc.2023-11-08
Cutter ™ Brand Hand SanitizerProduct nameUnited Industries Corporation | Forumlated Solutions LLC2020-08-10
HYDROXYUREA CAPSULES USPProduct namePhysicians Total Care, Inc.2012-06-01