FDA.reportPublic FDA data

TOPOTECAN HYDROCHLORIDE - Food and Drug Administration

Set ID
cbf6bf79-4ea9-419f-b7df-eefa780730bf
Type
Indexing - product concept
Effective date
2018-01-25
Version
2
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 1996Product nameFresenius Kabi USA, LLC | ScinoPharm Taiwan, Ltd.2026-01-14
These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. TOPOTECAN Injection Must be diluted before intravenous infusion Initial U.S. Approval: 1996Product nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-12-17
These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 1996Product nameFresenius Kabi USA, LLC2025-11-27
These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection , for intravenous use Initial U.S. Approval: 1996Product nameAccord Healthcare, Inc. | Intas Pharmaceuticals Limited2024-10-04
These highlights do not include all the information needed to use HYCAMTIN CAPSULES safely and effectively. See full prescribing information for HYCAMTIN CAPSULES. HYCAMTIN ® (topotecan) capsules, for oral use Initial U.S. Approval: 1996Product nameSandoz Inc2023-09-18
These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 1996Product nameActavis Pharma, Inc.2022-08-31
These highlights do not include all the information needed to use HYCAMTIN FOR INJECTION safely and effectively. See full prescribing information for HYCAMTIN FOR INJECTION. HYCAMTIN ® (topotecan) for injection, for intravenous use Initial U.S. Approval: 1996Product nameNovartis Pharmaceuticals Corporation2022-07-07
These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. TOPOTECAN injection, for intravenous use Initial U.S. Approval: 1996Product nameHospira, Inc. | Zydus Hospira Oncology Private Limited | Hospira Australia Pty Ltd2021-02-01
These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 1996Product nameMeitheal Pharmaceuticals Inc.2019-11-15
These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 1996Product nameBedford Laboratories | Dr. Reddy's Laboratories Limited | Cipla Ltd.2016-04-28