Is there a generic for Iobenguane sulfate i-131?

The FDA Orange Book does not currently list an approved generic (ANDA) for Iobenguane sulfate i-131. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Iobenguane sulfate i-131?

IOBENGUANE SULFATE I 131 (NDA 020084, PHARMALUCENCE) 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-131 are approved?

Iobenguane sulfate i-131 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iobenguane sulfate i-131

Iobenguane sulfate i-131 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:IOBENGUANE SULFATE I 131 · NDA 020084

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
IOBENGUANE SULFATE I 131	PHARMALUCENCE	NDA 020084	—	Mar 25, 1994

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-131 — frequently asked questions

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

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