Viewing data from:

IOHEXOL

ANDA

IOHEXOL | A217737 | AMNEAL EU LTD

1 strength0 unique patents1 unique exclusivity

Reference Listed Drug: OMNIPAQUE 300(TE code: AP)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

CGT

Jul. 26, 2026

API Supply Chain3 active DMFs3 inactive

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

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIOHEXOL USP

DMF 360382021

DIVI'S LABOTATORIES LTDIOHEXOL

DMF 381952023

SUZHOU RYWAY BIOTECH CO LTDIOHEXOL

DMF 423822025

ZHEJIANG STARRY PHARMACEUTICAL CO LTDInactiveIOHEXOL

DMF 225352009

HOVIONE FARMACIENCIA SAInactiveIOHEXOL

DMF 231482009

INTERPHARMA PRAHA ASInactiveIOHEXOL DRUG SUBSTANCE, FOR ORAL PRODUCTS

DMF 266412013

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

Approval Letters

1 letter from Drugs@FDA

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

Source: Drugs@FDA application documents.

Products (1)

#001 — 64.7%

0 patents1 exclusivity▴

SOLUTION;INJECTION, ORAL, RECTAL | Approved: Nov 13, 2025

Code	Date	Status
CGT	Jul 26, 2026	< 1 year