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As of Nov 15, 2026, ANDA 74637 (Iopamidol-300 In Plastic Container), held by Hospira, was first approved by FDA on Apr 3, 1997, with 1 approved supplement and 0 published complete response letters.
First approved: Apr 3, 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
Apr 3, 1997
Original application
Approved
None posted
Products
1 strengths and forms
Product
Active ingredient
Marketing
Iopamidol-300 In Plastic Container61% ยท injectable;injection
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
