Is there a generic for Gadodiamide?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gadodiamide. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Gadodiamide?

OMNISCAN (NDA 022066, GE HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadodiamide are approved?

Gadodiamide is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gadodiamide

Gadodiamide is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OMNISCAN · NDA 022066

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
OMNISCANRLD×2	GE HEALTHCARE	NDA 022066	—	Sep 05, 2007
OMNISCANRLD	GE HEALTHCARE	NDA 020123	—	Jan 08, 1993

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.

Gadodiamide — frequently asked questions

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

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