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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

ISOVUE READI

NDANot in Orange Book

IOPAMIDOL | N220583 | BRACCO

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs5 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

BRACCO IMAGING SPAIOPAMIDOL

DMF 106381993

DIVIS LABORATORIES LTDIOPAMIDOL USP

DMF 180662005

SUZHOU RYWAY BIOTECH CO LTDIOPAMIDOL

DMF 423862025

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIOPAMIDOL

DMF 280332013

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIOPAMIDOL USP

DMF 366832022

ZAMBON GROUP SPAInactiveIOPAMIDOL

DMF 105641993

HOVIONE SOCIEDADE QUIMICA SAInactiveIOPAMIDOL

DMF 112451994

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveIOPAMIDOL

DMF 122111996

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveIOPAMIDOL STEP #1

DMF 122801996

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveIOPAMIDOL, USP

DMF 124421997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 200MG

▴

SOLUTION; ORAL | Approved: Oct. 9, 2026

No patent or exclusivity listings for this strength.

#002 — 250MG

▾

SOLUTION; ORAL | Approved: Oct. 9, 2026

#003 — 300MG

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SOLUTION; ORAL | Approved: Oct. 9, 2026

#004 — 370MG

▾

SOLUTION; ORAL | Approved: Oct. 9, 2026