Details for New Drug Application (NDA): 022090

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NDA 022090 describes EOVIST, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the EOVIST profile page.

The generic ingredient in EOVIST is gadoxetate disodium. One supplier is listed for this compound. Additional details are available on the gadoxetate disodium profile page.

Summary for 022090

Tradename:	EOVIST
Applicant:	Bayer Hlthcare
Ingredient:	gadoxetate disodium
Patents:	0

Pharmacology for NDA: 022090

Mechanism of Action	Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 022090

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-320	50419-320-05	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE
EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-320	50419-320-15	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1.8143GM/10ML (181.43MG/ML)
Approval Date:	Jul 3, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	2.72145GM/15ML (181.43MG/ML)
Approval Date:	Feb 4, 2013	TE:		RLD:	Yes

Expired US Patents for NDA 022090

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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