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Last Updated: November 21, 2024

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. 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. Additional details are available on the gadopentetate dimeglumine profile page.
Summary for 021037
Tradename:MAGNEVIST
Applicant:Bayer Hlthcare
Ingredient:gadopentetate dimeglumine
Patents:0

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

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