Is there a generic for Iotrolan?

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

What is the reference-listed drug for Iotrolan?

OSMOVIST 190 (NDA 019580, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Iotrolan are approved?

Iotrolan is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iotrolan

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

Reference-listed drug:OSMOVIST 190 · NDA 019580

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
OSMOVIST 190×2	BAYER HLTHCARE	NDA 019580	—	Dec 07, 1989

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.

Iotrolan — frequently asked questions

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

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