Treats iron deficiency. NDA 212320, held by Shield Tx. Ferric Maltol.
As of Nov 13, 2026, NDA 212320 (Accrufer), held by Shield Tx, was first approved by FDA on Jul 25, 2019, with 5 approved supplements and 0 published complete response letters.
ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
| Dec 19, 2025 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Jul 25, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Accrufer30MG IRON · capsule;oral | Ferric Maltol | RxReference drug |
| Dec 19, 2025 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Sep 8, 2022 | Supplement 15Labeling · Standard review | Approved | |
| Jun 1, 2022 | Supplement 13Labeling · Standard review | Approved | |
| Feb 16, 2022 | Supplement 11Labeling · Standard review | Approved | |
| Oct 28, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Jul 25, 2019 | Original applicationNew molecular entity · Standard review | Approved |
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
