Viewing data from:

ULTRAVIST 370

NDA

IOPROMIDE | N020220 | BAYER HEALTHCARE PHARMACEUTICALS INC

5 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 Chain3 active DMFs2 inactive

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

BAYER AGIOPROMIDE

DMF 81781989

ALP PHARM BEIJING CO LTDIOPROMIDE

DMF 353562020

SUZHOU RYWAY BIOTECH CO LTDIOPROMIDE

DMF 423812025

DAEWOONG BIO INCInactiveIOPROMIDE

DMF 256802012

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveIOPROMIDE

DMF 382392023

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jun 21, 2023	SUPPL -55	View Letter (PDF)
May 26, 2023	SUPPL -54	View Letter (PDF)
Apr 27, 2023	SUPPL -56	View Letter (PDF)
Feb 22, 2022	SUPPL -52	View Letter (PDF)
Aug 2, 2019	SUPPL -47	View Letter (PDF)
Apr 27, 2018	SUPPL -46	View Letter (PDF)
Apr 4, 2018	SUPPL -45	View Letter (PDF)
Aug 2, 2017	SUPPL -43	View Letter (PDF)
Jul 10, 2015	SUPPL -41	View Letter (PDF)
May 4, 2012	SUPPL -36	View Letter (PDF)
Jan 20, 2010	SUPPL -35	View Letter (PDF)
Jan 5, 2010	SUPPL -33	View Letter (PDF)
Sep 6, 2007	SUPPL -27	View Letter (PDF)
Aug 15, 2005	SUPPL -22	View Letter (PDF)
Mar 16, 2004	SUPPL -18	View Letter (PDF)
May 29, 2003	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#004 — 31.2%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 10, 1995

#003 — 49.9%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 10, 1995

#002 — 62.3%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 10, 1995

#005 — 62.3%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 18, 2008

#001 — 76.9%

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 10, 1995

No patent or exclusivity listings for this strength.