Iopamidol

ANDA 74629, held by Baxter Hlthcare. Iopamidol.

As of Nov 15, 2026, ANDA 74629 (Iopamidol), held by Baxter Hlthcare, was first approved by FDA on Nov 6, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 6, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 6, 1996	Original application	Approved	Review

Products

4 strengths and forms


Iopamidol41% · injectable;injection	Iopamidol	Discontinued
Iopamidol61% · injectable;injection	Iopamidol	Discontinued
Iopamidol76% · injectable;injection	Iopamidol	Discontinued
Iopamidol51% · injectable;injection	Iopamidol	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 31, 1998	Supplement 2Manufacturing	Approved	None posted
Mar 31, 1998	Supplement 3Manufacturing	Approved	None posted
Mar 31, 1998	Supplement 4Labeling	Approved	None posted
Dec 3, 1997	Supplement 5Labeling	Approved	None posted
Jun 23, 1997	Supplement 1Manufacturing	Approved	None posted
Nov 6, 1996	Original application	Approved	Review

Identifiers

Application: ANDA 74629
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters