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IODIXANOL

ANDA

IODIXANOL | A214271 | JIANGSU HENGRUI PHARMACEUTICALS CO LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VISIPAQUE 270(TE code: AP)

API Supply Chain3 active DMFs2 inactive

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

JIANGSU HENGRUI PHARMACEUTICALS CO LTDIODIXANOL USP

DMF 312002017

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIODIXANOL USP

DMF 364682022

SUZHOU RYWAY BIOTECH CO LTDIODIXANOL

DMF 423872025

IMAX DIAGNOSTIC IMAGING HOLDING LTDInactiveIODIXANOL

DMF 274782013

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveIODIXANOL

DMF 392612023

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 25, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 55%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 19, 2022

No patent or exclusivity listings for this strength.

#002 — 65.2%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 19, 2022