ANDA 74679, held by Fresenius Kabi USA. Iopamidol.
As of Nov 15, 2026, ANDA 74679 (Iopamidol-250, Iopamidol-300, Iopamidol-370), held by Fresenius Kabi USA, was first approved by FDA on Apr 2, 1997, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 1997 | Original application | Approved | None posted |
| Dec 5, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Aug 21, 2000 | Supplement 3Manufacturing | Approved | None posted |
| Apr 2, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Oct 3, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Apr 2, 1997 | Original application | Approved | None posted |
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
