GADOFOSVESET TRISODIUM - Food and Drug Administration

Set ID: 3c495eba-e7eb-cf97-a376-25ae31b0cc54
Type: Indexing - Product Concept
Effective date: 2014-05-08
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2026-09-11
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG	2026-07-28
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH ES \| Sharp Corporation \| Quality Packaging Services International LLC \| Currenta GmbH & Co. OHG	2026-05-01
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2026-05-01
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH ES \| Sharp Corporation \| Quality Packaging Services International LLC \| Currenta GmbH & Co. OHG	2026-05-01
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	Product name	GE Healthcare \| GE Healthcare AS \| GE Healthcare AS avd Lindesnes \| GE Healthcare Shanghai Co., Ltd.	2026-04-30
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	Product name	GE Healthcare \| GE Healthcare AS \| GE Healthcare AS avd Lindesnes \| GE Healthcare Shanghai Co., Ltd.	2026-04-29
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	Product name	Bayer HealthCare Pharmaceuticals Inc.	2026-03-02
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2026-03-02
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH ES \| Sharp Corporation \| Quality Packaging Services International LLC \| Currenta GmbH & Co. OHG	2026-02-27
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	Product name	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Dynamit Nobel GmbH ES \| Sharp Corporation \| Quality Packaging Services International LLC \| Currenta GmbH & Co. OHG	2026-02-27
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	Product name	Fresenius Kabi USA, LLC \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)	2025-11-07
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	Product name	Fresenius Kabi USA, LLC \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)	2025-11-06
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	Product name	Fresenius Kabi USA, LLC \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)	2025-10-31
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	Product name	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)	2025-07-15
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	Product name	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd.	2025-04-17
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	Product name	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd.	2025-04-17
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	Product name	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd.	2025-04-17
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	Product name	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd. \| Anhui Poly Pharm. Co. Ltd.	2025-04-16
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	Product name	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd. \| Anhui Poly Pharm. Co. Ltd.	2025-04-16
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	Product name	BRACCO DIAGNOSTICS INC \| BRACCO IMAGING SPA \| BIPSO GmbH \| Labor LS SE & Co. KG \| PATHEON ITALIA SPA \| BioChem Labor für biologishe und chemische	2025-03-16
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	Product name	Guerbet LLC \| Recipharm Monts \| Simafex \| PCAS Finland O.y \| Liebel-Flarsheim Company LLC	2025-03-14
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	Product name	BRACCO DIAGNOSTICS INC \| BRACCO IMAGING SPA \| BIPSO GmbH \| Labor LS SE & Co. KG \| PATHEON ITALIA SPA \| BioChem Labor für biologishe und chemische	2025-03-14
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	Product name	Guerbet LLC \| Recipharm \| Simafex \| PCAS Finland O.y \| Liebel-Flarsheim Company LLC	2025-03-12
DRUG FACTS:	Product name	Energique, Inc. \| Apotheca Company	2024-10-29
DRUG FACTS:	Product name	21st Century Homeopathics \| Apotheca Company	2015-08-12
Bayer Healthcare, Inc. human prescription drug label with highlights	Product name	Bayer Healthcare, Inc.	2009-01-02

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
0270-5164	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
0270-5164-12	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
0270-5164-13	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
0270-5164-14	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
0270-5164-15	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
0270-5264	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
0270-5264-16	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
0270-5264-17	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
0407-2943	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.
0407-2943	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.
0407-2943-01	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.
0407-2943-02	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.
0407-2943-05	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.
0407-2943-06	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.
0407-2943-12	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.
0407-2943-17	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.
0407-2943-22	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.
0407-2943-70	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.
44911-0650	DRUG FACTS:	Energique, Inc. \| Apotheca Company
44911-0650-1	DRUG FACTS:	Energique, Inc. \| Apotheca Company
50419-310	Bayer Healthcare, Inc. DailyMed label	Bayer Healthcare, Inc.
50419-310-01	Bayer Healthcare, Inc. DailyMed label	Bayer Healthcare, Inc.
50419-310-02	Bayer Healthcare, Inc. DailyMed label	Bayer Healthcare, Inc.
50419-320	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.
50419-320-05	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.
50419-320-15	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.
50419-320-75	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.
50419-325	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
50419-325	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325	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
50419-325	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
50419-325-11	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-11	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
50419-325-12	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-12	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
50419-325-13	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-13	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
50419-325-14	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
50419-325-15	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
50419-325-18	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
50419-325-19	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
50419-325-27	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
50419-325-27	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-28	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
50419-325-28	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-29	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-29	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
50419-325-37	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-37	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
50419-325-67	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-67	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
50419-325-68	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
50419-325-68	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-69	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-69	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
50419-325-72	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
50419-325-72	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-73	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
50419-325-74	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
50419-325-75	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 Explosivistoff und Systemtechnik \| Sharp Corporation \| Quality Packaging Specialists International, LLC (QPSI) \| Currenta GmbH & Co. OHG
50419-325-75	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
63972-001	DRUG FACTS:	21st Century Homeopathics \| Apotheca Company
63972-001-02	DRUG FACTS:	21st Century Homeopathics \| Apotheca Company
65219-080	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)
65219-080-01	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)
65219-080-05	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)
65219-082	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)
65219-082-01	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)
65219-082-10	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)
65219-084	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)
65219-084-01	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)
65219-084-15	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)
65219-086	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)
65219-086-01	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)
65219-086-20	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)
65219-088	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)
65219-088-06	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)
65219-088-50	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)
65219-281	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)
65219-281-00	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)
65219-281-02	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)
65219-281-03	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)
65219-281-05	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)
65219-281-07	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)
65219-281-08	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)
65219-281-10	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)
65219-281-15	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)
65219-287	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)
65219-287-10	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)
65219-287-30	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)
65219-289	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)
65219-289-10	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)
65219-289-65	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)
67684-2000	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
67684-2000	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
67684-2000-0	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
67684-2000-1	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
67684-2000-2	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
67684-2000-3	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
67684-2000-4	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
67684-2000-5	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
67684-2000-6	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
67684-2000-7	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
67684-2001	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
67684-2001	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
67684-2001-0	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
67684-2001-1	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
67684-2001-2	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
67684-2001-3	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
67684-2001-4	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
67684-3001	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
67684-3001-1	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
67684-3001-2	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
67684-3001-3	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
70436-123	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.
70436-123	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.
70436-123-31	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.
70436-123-33	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.
70436-123-34	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.
70436-123-35	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.

GADOFOSVESET TRISODIUM - Food and Drug Administration

Mapped DailyMed Labels#

Related NDC Packages#