Details for New Drug Application (NDA): 021037

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NDA 021037 describes MAGNEVIST, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the MAGNEVIST profile page.

The generic ingredient in MAGNEVIST is gadopentetate dimeglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadopentetate dimeglumine profile page.

Summary for 021037

Tradename:	MAGNEVIST
Applicant:	Bayer Hlthcare
Ingredient:	gadopentetate dimeglumine
Patents:	0
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 021037

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-188	50419-188-11	10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-11) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-188	50419-188-58	10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-58) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	469.01MG/ML
Approval Date:	Mar 10, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021037

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	Start Trial	Start Trial
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	Start Trial	Start Trial
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	Start Trial	Start Trial
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	Start Trial	Start Trial
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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