Is there a generic for Iothalamate meglumine?

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

What is the reference-listed drug for Iothalamate meglumine?

CONRAY (NDA 013295, 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 Iothalamate meglumine are approved?

Iothalamate meglumine is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Iothalamate meglumine

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

Reference-listed drug:CONRAY · NDA 013295

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
CONRAYRLD×2	LIEBEL-FLARSHEIM	NDA 013295	—	Approved Prior to Jan 1, 1982
CONRAY 30RLD	LIEBEL-FLARSHEIM	NDA 016983	—	Approved Prior to Jan 1, 1982
CYSTO-CONRAY II	LIEBEL-FLARSHEIM	NDA 017057	—	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.

Iothalamate meglumine — frequently asked questions

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

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