Is there a generic for Ioversol?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ioversol. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Ioversol?

OPTIRAY 300 (NDA 020923, LIEBEL-FLARSHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ioversol are approved?

Ioversol is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ioversol

Ioversol is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OPTIRAY 300 · NDA 020923

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
OPTIRAY 300RLD×4	LIEBEL-FLARSHEIM	NDA 020923	—	May 13, 1999
OPTIRAY 240RLD×5	LIEBEL-FLARSHEIM	NDA 019710	—	Dec 30, 1988

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.

Ioversol — frequently asked questions

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

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