Details for New Drug Application (NDA): 210016

NDA 210016 describes CLARISCAN, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the CLARISCAN profile page.

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

Summary for 210016

Tradename:	CLARISCAN
Applicant:	Ge Healthcare
Ingredient:	gadoterate meglumine
Patents:	0

Pharmacology for NDA: 210016

Mechanism of Action

Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 210016

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943	0407-2943-70	10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTIC
CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016	ANDA	GE Healthcare	0407-2943	0407-2943-01	10 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	3.769GM/10ML (376.9MG/ML)
Approval Date:	Nov 1, 2019	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5.6535GM/15ML (376.9MG/ML)
Approval Date:	Nov 1, 2019	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	7.538GM/20ML (376.9MG/ML)
Approval Date:	Nov 1, 2019	TE:	AP	RLD:	No

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