Is there a generic for Iopromide?

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

What is the reference-listed drug for Iopromide?

ULTRAVIST (PHARMACY BULK) (NDA 021425, 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 Iopromide are approved?

Iopromide is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Iopromide

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

Reference-listed drug:ULTRAVIST (PHARMACY BULK) · NDA 021425

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ULTRAVIST (PHARMACY BULK)RLD×3	BAYER HLTHCARE	NDA 021425	—	Mar 12, 2004
ULTRAVIST 150RLD×5	BAYER HLTHCARE	NDA 020220	—	May 10, 1995

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.

Iopromide — frequently asked questions

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

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