Is there a generic for Iodamide meglumine?

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

What is the reference-listed drug for Iodamide meglumine?

RENOVUE-65 (NDA 017902, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iodamide meglumine are approved?

Iodamide meglumine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iodamide meglumine

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

Reference-listed drug:RENOVUE-65 · NDA 017902

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
RENOVUE-65	BRACCO	NDA 017902	—	Approved Prior to Jan 1, 1982
RENOVUE-DIP	BRACCO	NDA 017903	—	Approved Prior to Jan 1, 1982

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.

Iodamide meglumine — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo