Details for New Drug Application (NDA): 204781

NDA 204781 describes DOTAREM, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the DOTAREM profile page.

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

Summary for 204781

Tradename:	DOTAREM
Applicant:	Guerbet
Ingredient:	gadoterate meglumine
Patents:	0

Pharmacology for NDA: 204781

Mechanism of Action

Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 204781

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781	NDA	Guerbet LLC	67684-2000	67684-2000-4	6 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL
DOTAREM	gadoterate meglumine	SOLUTION;INTRAVENOUS	204781	NDA	Guerbet LLC	67684-2000	67684-2000-0	10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	37.69GM/100ML (376.9MG/ML)
Approval Date:	Mar 20, 2013	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	3.769GM/10ML (376.9MG/ML)
Approval Date:	Mar 20, 2013	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5.6535GM/15ML (376.9MG/ML)
Approval Date:	Mar 20, 2013	TE:	AP	RLD:	Yes

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