Optiray 240, Optiray 320, Optiray 350

NDA 20923, held by Liebel-Flarsheim. Ioversol.

As of Nov 13, 2026, NDA 20923 (Optiray 240, Optiray 320, Optiray 350), held by Liebel-Flarsheim, was first approved by FDA on May 29, 1998, with 14 approved supplements and 0 published complete response letters.

First approved: May 29, 1998
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures Adults: Computed tomography (CT) Imaging of Head and Body (320, 350 mg iodine/mL) Venography (320, 350 mg iodine/mL) Intravenous Excretory Urography (320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients:…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 29, 1998	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

4 strengths and forms


Optiray 24051% · injectable;injection	Ioversol	Discontinued
Optiray 32068% · injectable;injection	Ioversol	RxReference drug
Optiray 35074% · injectable;injection	Ioversol	RxReference drug
Optiray 30064% · injectable;injection	Ioversol	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Apr 25, 2023	Supplement 30Labeling · Standard review	Approved	Letter Label
Feb 18, 2022	Supplement 28Labeling · Standard review	Approved	Label Letter
Nov 18, 2020	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 18, 2020	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 12, 2017	Supplement 21Labeling · Standard review	Approved	Letter Label
Apr 26, 2017	Supplement 19Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 12, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Jul 6, 2015	Supplement 18Labeling · Standard review	Approved	Letter Label
Dec 19, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 8, 2009	Supplement 5Labeling · Standard review	Approved	None posted
Sep 12, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 14, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
May 13, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
May 29, 1998	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 20923
Drugs@FDA: Overview at FDA
Company: Liebel-Flarsheim Company

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters