Details for New Drug Application (NDA): 215304

NDA 215304 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 215304

Tradename:	GADOTERATE MEGLUMINE
Applicant:	Hengrui Pharma
Ingredient:	gadoterate meglumine
Patents:	0

Pharmacology for NDA: 215304

Mechanism of Action

Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 215304

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304	ANDA	Fresenius Kabi USA, LLC	65219-080	65219-080-05	10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL
GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304	ANDA	Fresenius Kabi USA, LLC	65219-082	65219-082-10	10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1.8845GM/5ML (376.9MG/ML)
Approval Date:	Apr 11, 2022	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:	Apr 11, 2022	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:	Apr 11, 2022	TE:	AP	RLD:	No

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