Is there a generic for Iothalamate sodium?

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

What is the reference-listed drug for Iothalamate sodium?

ANGIO-CONRAY (NDA 013319, 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 sodium are approved?

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

FDA Orange Book · active-ingredient family

Iothalamate sodium

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

Reference-listed drug:ANGIO-CONRAY · NDA 013319

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ANGIO-CONRAY	MALLINCKRODT	NDA 013319	—	Approved Prior to Jan 1, 1982
CONRAY 325	MALLINCKRODT	NDA 017685	—	Approved Prior to Jan 1, 1982
CONRAY 400	MALLINCKRODT	NDA 014295	—	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 sodium — frequently asked questions

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

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