Is there a generic for Gadoversetamide?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gadoversetamide. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Gadoversetamide?

OPTIMARK (NDA 020975, LIEBEL-FLARSHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadoversetamide are approved?

Gadoversetamide is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gadoversetamide

Gadoversetamide is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OPTIMARK · NDA 020975

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
OPTIMARKRLD	LIEBEL-FLARSHEIM	NDA 020975	—	Dec 08, 1999
OPTIMARKRLD×4	LIEBEL-FLARSHEIM	NDA 020937	—	Dec 08, 1999
OPTIMARK IN PLASTIC CONTAINERRLD×4	LIEBEL-FLARSHEIM	NDA 020976	—	Dec 08, 1999

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Gadoversetamide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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