Question 1

Is there a generic for Iohexol?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Iohexol, referencing the brand OMNIPAQUE 140. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Iohexol?

Accepted Answer

OMNIPAQUE 140 (NDA 018956, GE HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Iohexol have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Iohexol. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Iohexol are approved?

Accepted Answer

Iohexol is approved in the following dosage forms: for solution, injectable, solution.

Product	Applicant	Application	TE	Approved
OMNIPAQUE 140RLD×9	GE HEALTHCARE	NDA 018956	—	Nov 30, 1988
ORALTAG	INTERPHARMA PRAHA AS	NDA 205383	—	Mar 26, 2015
OMNIPAQUE 350×3	GE HEALTHCARE	NDA 020608	—	Oct 24, 1995

Iohexol

Brand (NDA) products · for solution, injectable, solution

Generic (ANDA) products (1)

Marketing exclusivity (1)

Listed patents

Iohexol — frequently asked questions

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