FDA.reportPublic FDA data

PALONOSETRON HYDROCHLORIDE - Food and Drug Administration

Set ID
06499cfd-dc01-4a13-ac2b-7239d959d760
Type
Indexing - product concept
Effective date
2018-01-24
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameBluePoint Laboratories | Dr.Reddy's Laboratories Limited | Gland Pharma Limited2026-08-25
These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. AKYNZEO® (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014 AKYNZEO® (fosnetupitant and palonosetron) for injection, for intravenous use Initial U.S. Approval: 2018Product nameHelsinn Therapeutics (U.S.), Inc. | Helsinn Healthcare SA | Helsinn Advanced Synthesis SA | Helsinn Birex Pharmaceuticals LTD | Baxter Oncology GmbH2026-06-23
These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. AKYNZEO® (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014 AKYNZEO® (fosnetupitant and palonosetron) for injection, for intravenous use Initial U.S. Approval: 2018Product nameHelsinn Therapeutics (U.S.), Inc. | Helsinn Healthcare SA | Helsinn Advanced Synthesis SA | Helsinn Birex Pharmaceuticals LTD | Patheon Italia S.p.A. | Baxter Oncology GmbH2026-01-26
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameNorthStar Rx LLC | Gland Pharma Limited2025-12-24
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED2025-10-30
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameApotex Corp. | Qilu Pharmaceutical (Hainan) Co., Ltd.2025-06-09
These highlights do not include all the information needed to use POSFREA safely and effectively. See full prescribing information for POSFREA. POSFREA TM (palonosetron) injection, for intravenous use Initial U.S. Approval: 2003Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC.2025-04-29
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameBluePoint Laboratories | Dr.Reddy's Laboratories Limited | Gland Pharma Limited2025-01-30
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameApotex Corp. | Qilu Pharmaceutical (Hainan) Co., Ltd.2025-01-02
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameAvenacy, Inc.2024-05-15
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HCl injection, for intravenous use Initial U.S. Approval: 2003Product nameSandoz Inc2024-02-05
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HCl injection, for intravenous use Initial U.S. Approval: 2003Product nameSandoz Inc2024-02-05
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HCl injection, for intravenous use Initial U.S. Approval: 2003Product nameSandoz Inc2024-02-05
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameMeitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.2023-08-17
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION<BR><BR>Palonosetron Hydrochloride Injection, for Intravenous Use<BR>Initial U.S. Approval: 2003Product nameCipla USA Inc. | Helsinn Advanced Synthesis SA | Helsinn Birex Pharmaceuticals Limited | Pierre Fabre Medicament Production | Oso Bio Pharmaceutical Manufacturing, LLC2022-01-13
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.2021-10-18
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE Injection, for intravenous use Initial U.S. Approval: 2003Product nameFresenius Kabi USA, LLC | Fresenius Kabi Austria2021-01-11
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE Injection, for intravenous use Initial U.S. Approval: 2003Product nameFresenius Kabi USA, LLC | Fresenius Kabi Austria2020-12-29
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameBaxter Healthcare Corporation2020-09-15
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameBaxter Healthcare Corporation2020-09-15
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameDr.Reddy's Laboratories Limited | Gland Pharma Limited2020-08-30
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION . PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameMylan Institutional LLC2020-06-09
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameSagent Pharmaceuticals2020-04-28
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameTeva Parenteral Medicines, Inc.2020-04-01
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003Product nameTeva Parenteral Medicines, Inc.2020-04-01
ALOXI ® (palonosetron HCl) Injection for Intravenous UseProduct nameMGI PHARMA2008-09-23