FDA.reportPublic FDA data

PEMETREXED DISODIUM HEPTAHYDRATE - Food and Drug Administration

Set ID
0976ea44-ea26-403d-a39d-71fffc6a3d33
Type
Indexing - product concept
Effective date
2025-02-25
Version
4
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameSagent Pharmaceuticals2026-09-21
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameMeitheal Pharmaceuticals Inc. | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.2026-08-21
These highlights do not include all the information needed to use PEMFEXY safely and effectively. See full prescribing information for PEMFEXY. PEMFEXY ™ (pemetrexed injection), for intravenous use Initial U.S. Approval: 2004Product nameEagle Pharmaceuticals, Inc.2026-02-20
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameSolco Healthcare US, LLC | Zhejiang Huahai Pharmaceutical Co., LTD2025-12-31
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameIngenus Pharmaceuticals, LLC | Qilu Pharmaceutical (Hainan) Co., Ltd.2025-12-23
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED injection, for intravenous use Initial U.S. Approval: 2004Product nameSandoz Inc.2025-12-16
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameMeitheal Pharmaceuticals Inc.2025-11-17
These highlights do not include all the information needed to use AXTLE safely and effectively. See full prescribing information for AXTLE. AXTLE TM (pemetrexed) for injection, for intravenous use Initial U.S. Approval: 2004Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC.2025-10-08
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED INJECTION, for intravenous use Initial U.S. Approval: 2004Product nameHospira, Inc. | Zydus Hospira Oncology Private Limited2025-10-08
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED FOR INJECTION, for Intravenous Use Initial U.S. Approval: 2004Product nameFresenius Kabi USA, LLC2025-08-31
These highlights do not include all the information needed to use PEMRYDI RTU safely and effectively. See full prescribing information for PEMRYDI RTU. PEMRYDI RTU (pemetrexed injection), for intravenous use Initial U.S. Approval: 2004Product nameAmneal Pharmaceuticals LLC | Zydus Lifesciences Limited2025-07-08
These highlights do not include all the information needed to use AXTLE safely and effectively. See full prescribing information for AXTLE. AXTLE TM (pemetrexed) for injection, for intravenous use Initial U.S. Approval: 2004Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC. | Gland Pharma Limited2025-06-18
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous use Initial U.S. Approval: 2004Product nameSomerset Therapeutics LLC | Reliance Life Sciences Private Limited2025-05-10
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameCamber Pharmaceuticals, Inc. | Hetero Labs Limited Unit VI2025-04-01
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameAvyxa Pharma, LLC | Avyxa Holdings, LLC. | Gland Pharma Limited2025-02-05
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED INJECTION, for intravenous use Initial U.S. Approval: 2004Product nameShilpa Medicare Limited | Zydus Lifesciences Limited2024-11-28
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION s afely and effectively. See full prescribing information for PEMETREXED FOR INJECTION . PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameApotex Corp | Apotex Inc | Gland Pharma Limited2024-11-13
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameSagent Pharmaceuticals2024-09-30
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameNorthStar RxLLC | Meitheal Pharmaceuticals Inc.2024-09-10
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED INJECTION, for intravenous use Initial U.S. Approval: 2004Product nameHospira, Inc. | Zydus Hospira Oncology Private Limited2024-07-24
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited2024-07-18
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameMeitheal Pharmaceuticals Inc.2024-04-19
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameMeitheal Pharmaceuticals Inc. | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.2024-04-19
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION . PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameBiocon Pharma Inc | Biocon Pharma Limited | MSN Laboratories Private Limited | Shilpa Medicare Limited2024-01-11
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION.PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameWaverley Pharma Inc | Reliance Life Sciences Pvt Ltd2023-12-30
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameBluePoint Laboratories | Apotex Inc | Gland Pharma Limited2023-10-10
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameBaxter Healthcare Company2023-09-25
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameBluePoint Laboratories | EUGIA Pharma Specialities Limited2023-09-05
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameEugia US LLC | EUGIA Pharma Specialities Limited2023-07-27
These highlights do not include all the information needed to use ALIMTA safely and effectively. See full prescribing information for ALIMTA. ALIMTA (pemetrexed for injection), for Intravenous Use Initial U.S. Approval: 2004Product nameEli Lilly and Company2023-05-19
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameBluePoint Laboratories | Apotex Inc | Gland Pharma Limited2023-04-26
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameBluePoint Laboratories | Apotex Inc | Gland Pharma Limited2023-04-26
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameMeitheal Pharmaceuticals Inc.2022-12-21
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameBluePoint Laboratories | Qilu Pharmaceutical (Hainan) Co., Ltd.2022-12-08
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED injection, for intravenous use Initial U.S. Approval: 2004Product nameTeva Pharmaceuticals, Inc.2022-12-01
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameDr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited-FTO72022-09-30
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED INJECTION, for intravenous use Initial U.S. Approval: 2004Product nameHospira, Inc. | Zydus Hospira Oncology Private Limited2022-07-19
Pemetrexed for injection, for Intravenous UseProduct nameZydus Lifesciences Limited | Zydus Hospira Oncology Private Limited2022-05-26
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004Product nameZydus Pharmaceuticals USA Inc. | Zydus Hospira Oncology Private Limited2022-05-26
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004Product nameQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.2021-08-13