Viewing data from:

ULTRAVIST (PHARMACY BULK)

NDA

IOPROMIDE | N021425 | BAYER HEALTHCARE PHARMACEUTICALS INC

3 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

15 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 62.3%

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 20, 2002

No patent or exclusivity listings for this strength.

#002 — 76.9%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 20, 2002

#003 — 49.9%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 12, 2004