Iopamidol

Sold as Isovue-M 200, Isovue-300, Isovue-370, Isovue-M 300, Isovue-128 and 3 more. Every FDA application for this active ingredient: 3 branded and 12 generic.

As of Nov 15, 2026, FDA lists 15 applications for Iopamidol (sold as Isovue-M 200, Isovue-300, Isovue-370 and others), first approved Dec 31, 1985, with 11 new uses approved and 0 published complete response letters.

First approved: Dec 31, 1985
Applications: 15
New uses approved: 11
Complete response letters: 0

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imagingMar 30, 2022

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following PancreatoduodenectomyDuodenal Neoplasm, Pancreatic Neoplasm · Masonic Cancer Center, University of Minnesota	Phase 2	Recruiting	May 13, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 31, 1985	Isovue-M 200, Isovue-300NDA 18735 · New molecular entity	Bracco	55	Marketed
Oct 12, 1994	Isovue-200, Isovue-250NDA 20327 · New formulation or manufacturer	Bracco	14	Marketed
Nov 6, 1996	IopamidolANDA 74629	Baxter Hlthcare	5	Discontinued
Apr 2, 1997	Iopamidol-250, Iopamidol-300ANDA 74679	Fresenius Kabi USA	4	Discontinued
Apr 3, 1997	Iopamidol-300 In Plastic ContainerANDA 74637	Hospira	1	Discontinued
Apr 30, 1997	Iopamidol-300ANDA 74638	Abbvie	0	Discontinued
Dec 30, 1997	Iopamidol-200 In Plastic Container, Iopamidol-250 In Plastic ContainerANDA 74636	Hospira	1	Discontinued
Dec 30, 1997	Iopamidol-200, Iopamidol-250ANDA 74898	Hospira	1	Discontinued
Feb 24, 1998	Iopamidol-250, Iopamidol-300ANDA 75005	Hospira	0	Discontinued
Jul 28, 2000	Iopamidol-200, Iopamidol-250ANDA 74881	Cook Imaging	2	Discontinued
Jun 18, 2010	Scanlux-300, Scanlux-370ANDA 90394	Sanochemia Corp USA	0	Discontinued
Feb 27, 2023	IopamidolANDA 215382	Hainan Poly	0	Marketed
Sep 27, 2023	IopamidolANDA 217134	Hainan Poly	1	Marketed
Oct 9, 2026	Isovue ReadiNDA 220583 · New formulation or manufacturer	Bracco	0	Marketed
—	IopamidolANDA 74734	Hospira	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA