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Last Updated: December 5, 2019

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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:DISCNDosage:INJECTABLE;INJECTIONStrength469.01MG/ML
Approval Date:Mar 10, 2000TE:RLD:Yes

Expired US Patents for NDA 021037

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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