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ISOVUE-200

NDA

IOPAMIDOL | N020327 | BRACCO DIAGNOSTICS INC

4 strengths0 unique patents0 unique exclusivities

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 DMFs4 inactive

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

BRACCO IMAGING SPAIOPAMIDOL

DMF 106381993

DIVIS LABORATORIES LTDIOPAMIDOL USP

DMF 180662005

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIOPAMIDOL

DMF 280332013

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIOPAMIDOL USP

DMF 366832022

SUZHOU RYWAY BIOTECH CO LTDIOPAMIDOL

DMF 423862025

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

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -28	View Letter (PDF)
Apr 27, 2023	SUPPL -25	View Letter (PDF)
Feb 22, 2022	SUPPL -23	View Letter (PDF)
Feb 26, 2018	SUPPL -14	View Letter (PDF)
Apr 12, 2017	SUPPL -12	View Letter (PDF)
Jan 25, 2016	SUPPL -11	View Letter (PDF)
Jul 9, 2015	SUPPL -10	View Letter (PDF)
Jun 24, 2014	SUPPL -8	View Letter (PDF)
Aug 3, 2012	SUPPL -7	View Letter (PDF)
Dec 11, 2003	SUPPL -4	View Letter (PDF)
Jul 23, 2003	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 41%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 12, 1994

No patent or exclusivity listings for this strength.

#002 — 51%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 12, 1994

#003 — 61%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 12, 1994

#004 — 76%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 12, 1994