MICAFUNGIN SODIUM - Food and Drug Administration

Set ID
9c331f34-aa42-465c-8abd-4e929fba4e94
Type
Indexing - product concept
Effective date
2025-06-25
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for Injection, for intravenous use Initial U.S. Approval: 2005Product nameHisun Pharmaceuticals USA, Inc.2026-04-14
Micafungin for Injection, for intravenous useProduct nameZydus Lifesciences Limited2025-12-22
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for Injection, for intravenous use Initial U.S. Approval: 2005Product nameHisun Pharmaceuticals USA, Inc.2025-12-17
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameNorthstar Rx LLC. | Zydus Lifesciences Limited2025-11-14
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameSagent Pharmaceuticals | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.2025-11-08
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameFresenius Kabi USA, LLC | Gland Pharma Limited2025-10-23
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameGlenmark Pharmaceuticals Inc., USA | Qilu Pharmaceutical (Hainan) Co., Ltd.2025-09-09
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for Injection, for intravenous use Initial U.S. Approval: 2005Product nameHikma Pharmaceuticals USA Inc.2025-08-22
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-01-20
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameFresenius Kabi USA, LLC | Gland Pharma Limited2024-10-09
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameFresenius Kabi USA, LLC | Gland Pharma Limited2024-10-09
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameMeitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.2024-08-13
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005Product nameQilu Pharmaceutical Co., Ltd | Qilu Pharmaceutical (Hainan) Co., Ltd.2024-05-10
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN FOR INJECTION, for intravenous use Initial U.S. Approval: 2005Product nameBiocon Pharma Inc. | Biocon Pharma Limited | Immacule Lifesciences Private Limited2023-10-04
These highlights do not include all the information needed to use MICAFUNGIN IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for MICAFUNGIN IN SODIUM CHLORIDE INJECTION . MICAFUNGIN IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 2005Product nameBaxter Healthcare Corporation2023-09-29
These highlights do not include all the information needed to use MICAFUNGIN IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for MICAFUNGIN IN SODIUM CHLORIDE INJECTION . MICAFUNGIN IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 2005Product nameBaxter Healthcare Corporation2023-09-29
These highlights do not include all the information needed to use MICAFUNGIN IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for MICAFUNGIN IN SODIUM CHLORIDE INJECTION . MICAFUNGIN IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 2005Product nameBaxter Healthcare Corporation2023-09-29
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous use Initial U.S. Approval: 2005 Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection). However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.Product namePar Health USA, LLC2021-06-05
These highlights do not include all the information needed to use MYCAMINE ® safely and effectively. See full prescribing information for MYCAMINE ® . MYCAMINE ® (micafungin for injection), for intravenous use Initial U.S. Approval: 2005Product nameAstellas Pharma US, Inc.2020-07-23