Is there a generic for Ioxaglate meglumine; ioxaglate sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ioxaglate meglumine; ioxaglate sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Ioxaglate meglumine; ioxaglate sodium?

HEXABRIX (NDA 018905, GUERBET) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ioxaglate meglumine; ioxaglate sodium are approved?

Ioxaglate meglumine; ioxaglate sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ioxaglate meglumine; ioxaglate sodium

Ioxaglate meglumine; ioxaglate sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:HEXABRIX · NDA 018905

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HEXABRIX	GUERBET	NDA 018905	—	Jul 26, 1985

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.

Ioxaglate meglumine; ioxaglate sodium — frequently asked questions

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

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