Details for New Drug Application (NDA): 020937

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NDA 020937 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 020937

Tradename:	OPTIMARK
Applicant:	Liebel-flarsheim
Ingredient:	gadoversetamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1654.5MG/5ML (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 020937

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-001	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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