FDA.reportPublic FDA data

RUFINAMIDE - Food and Drug Administration

Set ID
131b7904-af2d-e086-e6ed-019008086140
Type
Indexing - Product Concept
Effective date
2026-01-27
Version
9
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameAmerican Health Packaging2026-09-04
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameAscend Laboratories, LLC | Alkem Laboratories Limited2026-08-07
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameNovadoz Pharmaceuticals LLC | MSN Pharmaceuticals Inc.2026-06-12
These highlights do not include all the information needed to use RUFINAMIDE TABLETS safely and effectively. See full prescribing information for RUFINAMIDE TABLETS. RUFINAMIDE tablets, for oral use Initial U.S. Approval: 2008Product nameGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-23
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameAmerican Health Packaging2026-01-06
These highlights do not include all the information needed to use RUFINAMIDE TABLETS, USP safely and effectively. See full prescribing information for RUFINAMIDE TABLETS, USP. RUFINAMIDE tablets, for oral use Initial U.S. Approval: 2008Product nameLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-12-26
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-12-11
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameAmerican Health Packaging2025-11-17
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION . RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameBionpharma Inc. | CoreRx Inc. | OrBion Pharmaceuticals Private Limited2025-08-26
These highlights do not include all the information needed to use RUFINAMIDE TABLETS safely and effectively. See full prescribing information for RUFINAMIDE TABLETS. RUFINAMIDE tablets, for oral use Initial U.S. Approval: 2008Product nameAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-07-19
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-05-12
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameNorthStar RxLLC | Hetero Labs Limited Unit III2024-07-09
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameAscend Laboratories, LLC | Alkem Laboratories Limited2024-03-28
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameCamber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III2023-12-28
These highlights do not include all the information needed to use RUFINAMIDE TABLETS safely and effectively. See full prescribing information for RUFINAMIDE TABLETS. RUFINAMIDE tablet, for oral use Initial U.S. Approval: 2008Product nameMicro Labs Limited2023-05-17
These highlights do not include all the information needed to use BANZEL ® safely and effectively. See full prescribing information for BANZEL ® . BANZEL ® (rufinamide) film - coated t ablet, for o ral u se BANZEL ® (rufinamide) o ral s uspension Initial U.S. Approval: 2008Product nameEisai Inc. | Eisai Co., Ltd. | Ajinomoto Omnichem | Bushu Pharmaceuticals, Ltd. | Delpharm Huningue | Pace Analytical Life Sciences, LLC | Pharma Packaging Solutions, LLC dba Tjoapack, LLC2022-12-15
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameNovadoz Pharmaceuticals LLC | MSN Pharmaceuticals Inc.2022-01-02
These highlights do not include all the information needed to use RUFINAMIDE TABLETS safely and effectively. See full prescribing information for RUFINAMIDE TABLETS. RUFINAMIDE film-coated tablet, for oral use Initial U.S. Approval: 2008Product nameCamber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III2021-06-02
These highlights do not include all the information needed to use RUFINAMIDE TABLETS safely and effectively. See full prescribing information for RUFINAMIDE TABLETS. RUFINAMIDE tablets, for oral use. Initial U.S. Approval: 2008Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2021-05-31
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2020-09-05