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Last Updated: November 22, 2024

Suppliers and packages for tradename: GADOTERATE MEGLUMINE

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GADOTERATE MEGLUMINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123-56	6 VIAL in 1 CARTON (70436-123-56) / 100 mL in 1 VIAL (70436-123-40)	2024-06-28
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123-80	1 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40)	2024-06-28
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123-31	10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL	2024-06-28
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123-33	10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL	2024-06-28
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123-34	10 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL	2024-06-28
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123-35	10 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL	2024-06-28
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304	ANDA	Fresenius Kabi USA, LLC	65219-080-05	10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL	2022-06-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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