ANDA 213637, held by Bwxt Medcl. Iobenguane Sulfate I-123.
As of Nov 15, 2026, ANDA 213637 (Iobenguane I-123), held by Bwxt Medcl, was first approved by FDA on Dec 9, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Iobenguane I-12310mCi/5ML (2mCi/ML) ยท solution;intravenous | Iobenguane Sulfate I-123 | Discontinued |
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
