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Last Updated: December 12, 2025

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	9927MG/30ML (330.9MG/ML)
Approval Date:	Dec 8, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	3309MG/10ML (330.9MG/ML)
Approval Date:	Dec 8, 1999	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4963.5MG/15ML (330.9MG/ML)
Approval Date:	Dec 8, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020976

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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	⤷ Get Started Free	⤷ Get Started Free
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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