Is there a generic for Iothalamate meglumine; iothalamate sodium?

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

What is the reference-listed drug for Iothalamate meglumine; iothalamate sodium?

VASCORAY (NDA 016783, MALLINCKRODT) 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; iothalamate sodium are approved?

Iothalamate meglumine; iothalamate sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iothalamate meglumine; iothalamate sodium

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

Reference-listed drug:VASCORAY · NDA 016783

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
VASCORAY	MALLINCKRODT	NDA 016783	—	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; iothalamate sodium — 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