MIGLUSTAT - Food and Drug Administration

Set ID
a0eebf05-be5a-d3ca-e08a-9a2cbb283463
Type
Indexing - Product Concept
Effective date
2025-12-15
Version
5
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use MIGLUSTAT CAPSULES safely and effectively. See full prescribing information for MIGLUSTAT CAPSULES. MIGLUSTAT capsules, for oral use Initial U.S. Approval:2003Product nameNavinta LLC2025-12-31
These highlights do not include all the information needed to use YARGESA safely and effectively. See full prescribing information for YARGESA. YARGESA (miglustat) capsules, for oral use Initial U.S. Approval: 2003Product nameEdenbridge Pharmaceuticals LLC.2025-12-17
These highlights do not include all the information needed to use MIGLUSTAT CAPSULES safely and effectively. See full prescribing information for MIGLUSTAT CAPSULES. MIGLUSTAT capsules, for oral use Initial U.S. Approval: 2003Product nameANI Pharmaceuticals, Inc.2025-11-26
These highlights do not include all the information needed to use MIGLUSTAT CAPSULES safely and effectively. See full prescribing information for MIGLUSTAT CAPSULES. MIGLUSTAT capsules, for oral use Initial U.S. Approval: 2003Product nameZydus Pharmaceuticals USA Inc. | Navinta LLC2025-03-17
These highlights do not include all the information needed to use OPFOLDA ® safely and effectively. See full prescribing information for OPFOLDA. OPFOLDA (miglustat) capsules, for oral use Initial U.S. Approval: 2003Product nameAMICUS THERAPEUTICS US, LLC2024-11-27
These highlights do not include all the information needed to use miglustat safely and effectively. See full prescribing information for miglustat. miglustat capsules, for oral use Initial U.S. Approval: 2003Product nameCoTherix, Inc. | Almac Pharma Services Ltd. | Lonza AG2023-04-25
These highlights do not include all the information needed to use ZAVESCA safely and effectively. See full prescribing information for ZAVESCA. ZAVESCA ® (miglustat) capsules, for oral use Initial U.S. Approval: 2003Product nameActelion Pharmaceuticals US, Inc. | Almac Pharma Services Limited | Lonza AG2023-04-20
Miglustat (4237.G)Product nameVeranova, L.P.2022-11-09