| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Hospira, Inc. | Zydus Hospira Oncology Private Limited | 20260427 | 28 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Hospira, Inc. | Zydus Hospira Oncology Private Limited | 20260427 | 11 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Hikma Pharmaceuticals USA Inc. | 20251024 | 4 |
| These highlights do not include all the information needed to use INLEXZO safely and effectively. See full prescribing information for INLEXZO. INLEXZO™ (gemcitabine intravesical system) Initial U.S. Approval: 2025 | Janssen Biotech, Inc | Shilpa Pharma Lifesciences Limited | Sterigenics U.S., LLC | Eurofins Biolab Srl | Janssen Pharmaceutica NV | Johnson & Johnson Private Limited | Alcami Carolinas Corporation | AndersonBrecon Inc. | BSP Pharmaceuticals SpA | Corden Pharma GmbH | Catalent CTS, LLC | Labor LS SE & Co. KG | Isomedix Operations, Inc. A STERIS Company | STERIS Laboratories | NACS, Inc. | 20250911 | 1 |
| These highlights do not include all the information needed to use AVGEMSI safely and effectively. See full prescribing information for AVGEMSI. AVGEMSI TM (gemcitabine) injection, for intravenous use Initial U.S. Approval: 1996 | Avyxa Pharma, LLC | Avyxa Holdings, LLC | Ingenus Pharmaceuticals GmbH | 20250804 | 3 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Meitheal Pharmaceuticals Inc. | 20250723 | 1 |
| Gemcitabine, QA383E | Evonik Corporation | 20250627 | 9 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, for intravenous use Initial U.S. Approval: 1996 | NorthStar Rx LLC | 20250203 | 4 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Sagent Pharmaceuticals | 20250203 | 8 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, for intravenous use Initial U.S. Approval: 1996 | Meitheal Pharmaceuticals Inc. | 20250129 | 5 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE FOR INJECTION, for intravenous use Initial U.S. Approval: 1996 | Teyro Labs Private Limited | 20250109 | 1 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Mylan Institutional LLC | 20241111 | 6 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION, USP safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION, USP. GEMCITABINE for injection, USP, for intravenous use Initial U.S. Approval:1996 | Fresenius Kabi USA, LLC | 20241014 | 19 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, for intravenous use Initial U.S. Approval: 1996 | Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited-FTO7 | Cipla Limited | Kindos Pharmaceuticals Co., Ltd. | 20240909 | 16 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, for intravenous use Initial U.S. Approval: 1996 | Gland Pharma Limited | 20240906 | 14 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, powder, lyophilized, for solution, for intravenous use Initial U.S. Approval: 1996 | Sagent Pharmaceuticals | 20240906 | 12 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, for intravenous use Initial U.S. Approval: 1996 | Hospira, Inc. | Zydus Hospira Oncology Private Limited | 20240816 | 27 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION. GEMCITABINE for injection, for intravenous use Initial U.S. Approval: 1996 | Hospira, Inc. | Zydus Hospira Oncology Private Limited | 20240816 | 27 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | Meitheal Pharmaceuticals Inc. | 20240805 | 7 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996 | BluePoint Laboratories | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 20230911 | 5 |
| These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION, USP safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION, USP. GEMCITABINE for injection, USP, for intravenous use Initial U.S. Approval:1996 | Fresenius Kabi USA, LLC | 20210120 | 4 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use. Initial U.S. Approval: 1996 | Armas Pharmaceuticals Inc. | 20200110 | 1 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use. Initial U.S. Approval: 1996 | Armas Pharmaceuticals Inc. | 20200104 | 1 |
| These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use. Initial U.S. Approval: 1996 | Armas Pharmaceuticals Inc. | 20200104 | 1 |
| These highlights do not include all the information needed to use gemcitabine for injection safely and effectively. See full prescribing information for gemcitabine for injection. Gemcitabine For Injection, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996 | Bedford Laboratories | Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited-FTO7 | 20140514 | 5 |