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Generated: November 19, 2018

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Details for New Drug Application (NDA): 020976

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NDA 020976 describes OPTIMARK IN PLASTIC CONTAINER, which is a drug marketed by Liebel-flarsheim and is included in one NDA. Additional details are available on the OPTIMARK IN PLASTIC CONTAINER profile page.

The generic ingredient in OPTIMARK IN PLASTIC CONTAINER is gadoversetamide. There is one drug master file entry for this compound. Additional details are available on the gadoversetamide profile page.
Summary for 020976
Tradename:OPTIMARK IN PLASTIC CONTAINER
Applicant:Liebel-flarsheim
Ingredient:gadoversetamide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength9927MG/30ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3309MG/10ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength4963.5MG/15ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Expired US Patents for NDA 020976

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Liebel-flarsheim OPTIMARK IN PLASTIC CONTAINER gadoversetamide INJECTABLE;INJECTION 020976-001 Dec 8, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Liebel-flarsheim OPTIMARK IN PLASTIC CONTAINER gadoversetamide INJECTABLE;INJECTION 020976-001 Dec 8, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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