Iopamidol-200 In Plastic Container, Iopamidol-250 In Plastic Container, Iopamidol-300 In Plastic Container

As of Nov 15, 2026, ANDA 74636 (Iopamidol-200 In Plastic Container, Iopamidol-250 In Plastic Container, Iopamidol-300 In Plastic Container), held by Hospira, was first approved by FDA on Dec 30, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 30, 1997
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 30, 1997	Original application	Approved	None posted

Products

4 strengths and forms


Iopamidol-200 In Plastic Container41% · injectable;injection	Iopamidol	Discontinued
Iopamidol-250 In Plastic Container51% · injectable;injection	Iopamidol	Discontinued
Iopamidol-300 In Plastic Container61% · injectable;injection	Iopamidol	Discontinued
Iopamidol-370 In Plastic Container76% · injectable;injection	Iopamidol	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 1, 2002	Supplement 1Manufacturing	Approved	None posted
Dec 30, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74636
Drugs@FDA: Overview at FDA
Company: Hospira

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