NDA 19580, held by Bayer Hlthcare. Iotrolan.
As of Nov 13, 2026, NDA 19580 (Osmovist 190, Osmovist 240), held by Bayer Hlthcare, was not approved, with 0 approved supplements and 0 published complete response letters.
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
