Is there a generic for Iobenguane sulfate i-123?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Iobenguane sulfate i-123, referencing the brand ADREVIEW. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Iobenguane sulfate i-123?

ADREVIEW (NDA 022290, GE HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iobenguane sulfate i-123 are approved?

Iobenguane sulfate i-123 is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Iobenguane sulfate i-123

Iobenguane sulfate i-123 is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ADREVIEW · NDA 022290

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
ADREVIEWRLD	GE HEALTHCARE	NDA 022290	—	Sep 19, 2008

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
IOBENGUANE I-123	BWXT MEDCL	ANDA 213637	—	Dec 09, 2024

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.

Iobenguane sulfate i-123 — frequently asked questions

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

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