Is there a generic for Iodohippurate sodium i-131?

The FDA Orange Book does not currently list an approved generic (ANDA) for Iodohippurate sodium i-131. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Iodohippurate sodium i-131?

HIPPURAN I 131 (NDA 016666, MALLINCKRODT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iodohippurate sodium i-131 are approved?

Iodohippurate sodium i-131 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iodohippurate sodium i-131

Iodohippurate sodium i-131 is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:HIPPURAN I 131 · NDA 016666

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HIPPURAN I 131	MALLINCKRODT	NDA 016666	—	Approved Prior to Jan 1, 1982
HIPPUTOPE	BRACCO	NDA 015419	—	Approved Prior to Jan 1, 1982
IODOHIPPURATE SODIUM I 131	PHARMALUCENCE	NDA 017313	—	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.

Iodohippurate sodium 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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