FDA.reportPublic FDA data

BEXAROTENE - Food and Drug Administration

Set ID
ee2ef5df-ff93-4bcb-a381-12cdedb7612c
Type
Indexing - product concept
Effective date
2023-01-13
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES . BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameMylan Pharmaceuticals Inc.2026-05-15
Bexarotene Capsules Rx Only These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. Initial U.S. Approval: 1999Product nameAvKARE2025-10-13
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameANI Pharmaceuticals, Inc.2025-09-12
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameCamber Pharmaceuticals, Inc. | Ascent pharmaceutical Inc2025-01-20
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameAscent pharmaceutical Inc2024-07-31
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameActavis Pharma, Inc.2024-02-29
Bexarotene Gel, 1% Rx OnlyProduct nameAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2023-12-29
Bexarotene Capsules Rx Only These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. Initial U.S. Approval: 1999Product nameAvKARE2023-04-14
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameUpsher-Smith Laboratories, Inc. | Douglas Manufacturing limited2023-03-31
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC2022-12-30
These highlights do not include all the information needed to use TARGRETIN safely and effectively. See full prescribing information for TARGRETIN. TARGRETIN ® (bexarotene) capsules, for oral use Initial U.S. Approval: 1999Product nameBausch Health US, LLC | Catalent Pharma Solutions LLC2020-04-30
These highlights do not include all the information needed to use TARGRETIN safely and effectively. See full prescribing information for TARGRETIN. TARGRETIN ® (bexarotene) capsules, for oral use Initial U.S. Approval: 1999Product nameBausch Health US, LLC | Catalent Pharma Solutions LLC2020-04-30
Targretin ® (bexarotene) gel 1% Rx onlyProduct nameBausch Health US, LLC | DPT Laboratories, Ltd.2020-02-03
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES . BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999Product nameMylan Pharmaceuticals Inc.2018-06-13
Targretin ® (bexarotene) gel 1%Product nameLigand Pharmaceuticals Inc.2006-03-28