Is there a generic for Iofetamine hydrochloride i-123?

The FDA Orange Book does not currently list an approved generic (ANDA) for Iofetamine hydrochloride i-123. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Iofetamine hydrochloride i-123?

SPECTAMINE (NDA 019432, IMP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iofetamine hydrochloride i-123 are approved?

Iofetamine hydrochloride i-123 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iofetamine hydrochloride i-123

Iofetamine hydrochloride i-123 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SPECTAMINE · NDA 019432

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
SPECTAMINE	IMP	NDA 019432	—	Dec 24, 1987

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.

Iofetamine hydrochloride 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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