FDA.reportPublic FDA data

FLUVOXAMINE MALEATE - Food and Drug Administration

Set ID
cf9608ac-e3cb-2ff5-9afb-dc9a0d25234d
Type
Indexing - Product Concept
Effective date
2025-05-15
Version
3
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameApotex Corp | Apotex Inc.2026-09-11
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008Product namePar Health USA, LLC2026-06-24
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameREMEDYREPACK INC.2026-04-23
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product namePreferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc..2026-04-22
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product namePreferred Pharmaceuticals, Inc.2026-04-22
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameBryant Ranch Prepack2026-02-04
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameBryant Ranch Prepack2026-01-29
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameBryant Ranch Prepack2026-01-28
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameREMEDYREPACK INC.2026-01-26
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameREMEDYREPACK INC.2026-01-13
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameUpsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc2025-12-11
Fluvoxamine Maleate Extended-Release Capsules These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. Initial U.S. Approval: 2008Product nameAvKARE2025-12-04
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral use Initial U.S. Approval: 2008Product nameAjanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | Ajanta Pharma Ltd., Dahej2025-11-04
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameA-S Medication Solutions2025-10-21
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product namePD-Rx Pharmaceuticals, Inc.2025-10-01
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameApotex Corp | Apotex Inc.2025-09-18
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product namePreferred Pharmaceuticals Inc.2025-09-04
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules for oral administration Initial U.S. Approval: 2008Product nameCamber Pharmaceuticals, Inc. | Annora Pharma Private Limited2025-08-30
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameREMEDYREPACK INC.2025-08-21
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameANI Pharmaceuticals, Inc.2025-08-04
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral use Initial U.S. Approval: 2008Product nameActavis Pharma, Inc.2025-05-28
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameA-S Medication Solutions2025-05-15
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral use Initial U.S. Approval: 2008Product nameActavis Pharma, Inc.2025-05-01
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameBionpharma Inc. | OrBion Pharmaceuticals Private Limited2025-03-05
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameBionpharma Inc. | OrBion Pharmaceuticals Private Limited2025-02-12
Fluvoxamine Maleate Tablets These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameChartwell RX, LLC2025-01-23
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral use Initial U.S. Approval: 2008Product nameBionpharma Inc. | OrBion Pharmaceuticals Private Limited2024-05-28
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008Product nameEndo USA, Inc.2023-10-31
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994Product nameNuCare Pharmaceuticals,Inc.2021-01-29
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE Tablets for oral administration Initial U.S. Approval: 1994Product nameCarilion Materials Management2017-12-28
Fluvoxamine Maleate Tablets These highlights do not include all the information needed to use Fluvoxamine Maleate Tablets safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets. Fluvoxamine Maleate Tablets for oral administration Initial U.S. Approval: 1994Product nameAidarex Pharmaceuticals LLC2014-01-02
InsertProduct nameStat Rx USA2009-10-27
Fluvoxamine Maleate TabletsProduct nameSynthon Pharmaceuticals, Inc.2007-09-20