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Last Updated: December 14, 2019

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Details for New Drug Application (NDA): 020975

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NDA 020975 describes OPTIMARK, which is a drug marketed by Liebel-flarsheim and is included in three NDAs. Additional details are available on the OPTIMARK profile page.

The generic ingredient in OPTIMARK is gadoversetamide. There is one drug master file entry for this compound. Additional details are available on the gadoversetamide profile page.
Summary for 020975
Tradename:OPTIMARK
Applicant:Liebel-flarsheim
Ingredient:gadoversetamide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength16.545GM/50ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Expired US Patents for NDA 020975

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Liebel-flarsheim OPTIMARK gadoversetamide INJECTABLE;INJECTION 020975-001 Dec 8, 1999   Start Trial   Start Trial
Liebel-flarsheim OPTIMARK gadoversetamide INJECTABLE;INJECTION 020975-001 Dec 8, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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