Details for New Drug Application (NDA): 218073

NDA 218073 describes GADOTERATE MEGLUMINE, which is a drug marketed by Hainan Poly and Hengrui Pharma and is included in two NDAs. It is available from two suppliers. Additional details are available on the GADOTERATE MEGLUMINE profile page.

The generic ingredient in GADOTERATE MEGLUMINE is gadoterate meglumine. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.

Summary for 218073

Tradename:	GADOTERATE MEGLUMINE
Applicant:	Hainan Poly
Ingredient:	gadoterate meglumine
Patents:	0

Pharmacology for NDA: 218073

Mechanism of Action

Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 218073

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123	70436-123-56	6 VIAL in 1 CARTON (70436-123-56) / 100 mL in 1 VIAL (70436-123-40)
GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073	ANDA	Slate Run Pharmaceuticals, LLC	70436-123	70436-123-80	1 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1.8845GM/5ML (376.9MG/ML)
Approval Date:	Jun 17, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	3.769GM/10ML (376.9MG/ML)
Approval Date:	Jun 17, 2024	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5.6535GM/15ML (376.9MG/ML)
Approval Date:	Jun 17, 2024	TE:	AP	RLD:	No

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