| These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011 | Bayer HealthCare Pharmaceuticals Inc. | Bayer AG | Dynamit Nobel GmbH ES | Sharp Corporation | Quality Packaging Services International LLC | Currenta GmbH & Co. OHG | 20260501 | 26 |
| These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011 | Bayer HealthCare Pharmaceuticals Inc. | Bayer AG | 20260501 | 13 |
| These highlights do not include all the information needed to use GADAVIST safely and effectively. See full prescribing information for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial U.S. Approval: 2011 | Bayer HealthCare Pharmaceuticals Inc. | Bayer AG | Dynamit Nobel GmbH ES | Sharp Corporation | Quality Packaging Services International LLC | Currenta GmbH & Co. OHG | 20260501 | 23 |
| These highlights do not include all the information needed to use CLARISCAN safely and effectively. See full prescribing information for CLARISCAN. CLARISCAN™ (gadoterate meglumine) injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013 | GE Healthcare | GE Healthcare AS | GE Healthcare AS avd Lindesnes | GE Healthcare Shanghai Co., Ltd. | 20260430 | 12 |
| These highlights do not include all the information needed to use CLARISCAN safely and effectively. See full prescribing information for CLARISCAN. CLARISCAN™ (gadoterate meglumine) injection for intravenous use Initial U.S. Approval: 2013 | GE Healthcare | GE Healthcare AS | GE Healthcare AS avd Lindesnes | GE Healthcare Shanghai Co., Ltd. | 20260429 | 16 |
| These highlights do not include all the information needed to use EOVIST® safely and effectively. See full prescribing information for EOVIST. EOVIST (gadoxetate disodium) injection, for intravenous use Initial U.S. Approval: 2008 | Bayer HealthCare Pharmaceuticals Inc. | 20260302 | 25 |
| These highlights do not include all the information needed to use GADOTERATE MEGLUMINE INJECTION safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION. GADOTERATE MEGLUMINE injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013 | Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) | 20251107 | 2 |
| These highlights do not include all the information needed to use GADOTERATE MEGLUMINE INJECTION safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION. GADOTERATE MEGLUMINE injection for intravenous use Initial U.S. Approval: 2013 | Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) | 20251106 | 4 |
| These highlights do not include all the information needed to use GADOBUTROL INJECTION safely and effectively. See full prescribing information for GADOBUTROL INJECTION. GADOBUTROL injection, for intravenous use Initial U.S. Approval: 2011 IMAGING BULK PACKAGE NOT FOR DIRECT INFUSION | Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) | 20251031 | 4 |
| These highlights do not include all the information needed to use GADOBUTROL INJECTION safely and effectively. See full prescribing information for GADOBUTROL INJECTION. GADOBUTROL injection, for intravenous use Initial U.S. Approval: 2011 | Fresenius Kabi USA, LLC | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) | 20250715 | 3 |
| These highlights do not include all the information needed to use GADOBUTROL INJECTION safely and effectively. See full prescribing information for GADOBUTROL INJECTION. GADOBUTROL injection, for intravenous use Initial U.S. Approval: 2011 | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 20250417 | 4 |
| These highlights do not include all the information needed to use GADOBUTROL INJECTION safely and effectively. See full prescribing information for GADOBUTROL INJECTION. GADOBUTROL injection, for intravenous use Initial U.S. Approval: 2011 IMAGING BULK PACKAGE NOT FOR DIRECT INFUSION | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 20250417 | 1 |
| These highlights do not include all the information needed to use GADOBUTROL INJECTION safely and effectively. See full prescribing information for GADOBUTROL INJECTION. GADOBUTROL injection, for intravenous use Initial U.S. Approval: 2011 PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 20250417 | 1 |
| These highlights do not include all the information needed to use GADOTERATE MEGLUMINE INJECTION, USP safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION, USP. Gadoterate Meglumine Injection, USP, for intravenous use Initial U.S. Approval: 2013 | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | Anhui Poly Pharm. Co. Ltd. | 20250416 | 4 |
| These highlights do not include all the information needed to use GADOTERATE MEGLUMINE INJECTION, USP safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION, USP. Gadoterate Meglumine Injection, USP, for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013 | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | Anhui Poly Pharm. Co. Ltd. | 20250416 | 4 |
| These highlights do not include all the information needed to use MULTIHANCE safely and effectively. See full prescribing information for MULTIHANCE. MultiHance (gadobenate dimeglumine) Injection Initial U.S. Approval: 2004 | BRACCO DIAGNOSTICS INC | BRACCO IMAGING SPA | BIPSO GmbH | Labor LS SE & Co. KG | PATHEON ITALIA SPA | BioChem Labor für biologishe und chemische | 20250316 | 22 |
| These highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM ® (gadoterate meglumine) Injection for intravenous use Initial U.S. Approval: 2013 | Guerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC | 20250314 | 25 |
| These highlights do not include all the information needed to use MULTIHANCE safely and effectively. See full prescribing information for MULTIHANCE. MultiHance (gadobenate dimeglumine) Injection Initial U.S. Approval: 2004 | BRACCO DIAGNOSTICS INC | BRACCO IMAGING SPA | BIPSO GmbH | Labor LS SE & Co. KG | PATHEON ITALIA SPA | BioChem Labor für biologishe und chemische | 20250314 | 20 |
| These highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM ® (gadoterate meglumine) Injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013 | Guerbet LLC | Recipharm | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC | 20250312 | 17 |