NDA 20292, held by Otsuka. Ferric Ammonium Citrate.
As of Nov 13, 2026, NDA 20292 (Ferriseltz), held by Otsuka, was first approved by FDA on Oct 14, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ferriseltz600MG/PACKET · for solution;oral | Ferric Ammonium Citrate | 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
