FDA.reportPublic FDA data

POMALIDOMIDE - Food and Drug Administration

Set ID
191ddea2-3e27-5c8d-dccc-59ef9a0abcf7
Type
Indexing - Product Concept
Effective date
2025-04-01
Version
2
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES . POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameApotex Corp. | Apotex Inc.2026-03-11
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES. POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameBreckenridge Pharmaceutical, Inc. | Natco Pharma Ltd.2026-03-04
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES. POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameCamber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V2026-03-04
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES . POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameTeva Pharmaceuticals, Inc.2026-03-02
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES. POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameAurobindo Pharma Limited | Apicore Pharmaceuticals Private Limited | EUGIA Pharma Specialities Limited2026-01-30
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES. POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameBreckenridge Pharmaceutical, Inc. | Natco Pharma Ltd.2025-11-24
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES. POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameNatco Pharma Limited2025-11-18
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES . POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameTeva Pharmaceuticals, Inc.2025-10-23
These highlights do not include all the information needed to use POMALIDOMIDE CAPSULES safely and effectively. See full prescribing information for POMALIDOMIDE CAPSULES . POMALIDOMIDE capsules, for oral use Initial U.S. Approval: 2013Product nameTeva Pharmaceuticals, Inc.2025-10-01
Risk Evaluation and Mitigation Strategy (REMS) Document PS-Pomalidomide Shared System REMSProduct nameBristol Myers Squibb2025-02-26
These highlights do not include all the information needed to use POMALYST safely and effectively. See full prescribing information for POMALYST. POMALYST ® (pomalidomide) capsules, for oral use Initial U.S. Approval: 2013Product nameCelgene Corporation2025-02-26