FDA.reportPublic FDA data

IRINOTECAN HYDROCHLORIDE - Food and Drug Administration

Set ID
cfce77d6-e90b-6280-14b8-e6a66a38ebbc
Type
Indexing - Product Concept
Effective date
2021-05-25
Version
7
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameBluePoint Laboratories | Gland Pharma Limited2026-08-26
These highlights do not include all the information needed to use CAMPTOSAR safely and effectively. See full prescribing information for CAMPTOSAR. CAMPTOSAR ® (irinotecan hydrochloride) injection, for intravenous use Initial U.S. Approval: 1996Product namePharmacia & Upjohn Company LLC | Zydus Hospira Oncology Private Limited2026-05-12
These highlights do not include all the information needed to use CAMPTOSAR safely and effectively. See full prescribing information for CAMPTOSAR. CAMPTOSAR ® (irinotecan hydrochloride) injection, for intravenous use Initial U.S. Approval: 1996Product namePharmacia & Upjohn Company LLC | Zydus Hospira Oncology Private Limited2026-04-27
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameIngenus Pharmaceuticals, LLC2026-03-07
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameXiromed LLC | Gland Pharma Limited2026-02-19
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameSagent Pharmaceuticals | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)2026-02-06
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameIngenus Pharmaceuticals, LLC | Novast Laboratories , Ltd.2025-12-10
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION, USP. IRINOTECAN HYDROCHLORIDE INJECTION, USP, for intravenous use Initial U.S. Approval: 1996Product nameHospira, Inc. | Zydus Hospira Oncology Private Limited2025-11-03
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameEugia US LLC | EUGIA Pharma Specialities Limited2025-06-05
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameActavis Pharma, Inc.2025-05-31
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameBluePoint Laboratories | Gland Pharma Limited2025-03-19
These highlights do not include all the information needed to use ONIVYDE safely and effectively. See full prescribing information for ONIVYDE ONIVYDE® (irinotecan liposome injection), for intravenous use Initial U.S. Approval: 1996Product nameIpsen Biopharmaceuticals, Inc. | ScinoPharm Taiwan Ltd. | Hubei Haosun Pharmaceuticals Co. Ltd | Ipsen Pharma Biotech | Boston Analytical | Quality Chemical Laboratories (QCL) | Avista2025-03-03
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION, USP. IRINOTECAN HYDROCHLORIDE INJECTION, USP, for intravenous use Initial U.S. Approval: 1996Product nameHospira, Inc. | Zydus Hospira Oncology Private Limited2025-01-16
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameApotex Corp. | Qilu Pharmaceutical (Hainan) Co., Ltd.2024-07-04
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameApotex Corp. | Qilu Pharmaceutical (Hainan) Co., Ltd.2024-06-28
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, intravenous infusion Initial U.S. Approval: 1996Product nameIntas Pharmaceuticals | Intas Pharmaceuticals Limited2023-12-02
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996 Rx onlyProduct nameFresenius Kabi USA, LLC2023-01-19
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameNorthstar Rx LLC | Gland Pharma Limited2022-03-31
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameGland Pharma Limited2022-03-03
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.2021-03-10
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996Product nameAreva Pharmaceuticals, Inc.2021-01-14
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous infusion Initial U.S. Approval: 1996Product nameArmas Pharmaceuticals Inc.2020-09-07
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous infusion Initial U.S. Approval: 1996Product nameArmas Pharmaceuticals Inc.2020-09-07
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous infusion Initial U.S. Approval: 1996Product nameArmas Pharmaceuticals Inc.2020-09-03
These highlights do not include all the information needed to use irinotecan hydrochloride injection safely and effectively. See full prescribing information for Irinotecan Hydrochloride Injection, USP. Irinotecan Hydrochloride Injection, USP Initial U.S. Approval: 1996Product nameHikma Pharmaceuticals USA Inc. | THYMOORGAN GMBH PHARMAZIE2020-06-28
These highlights do not include all the information needed to use irinotecan hydrochloride injection safely and effectively. See full prescribing information for Irinotecan Hydrochloride Injection, USP. Irinotecan Hydrochloride Injection, USP Initial U.S. Approval: 1996Product nameHikma Pharmaceuticals USA Inc. | THYMOORGAN GMBH PHARMAZIE2020-06-23