Treats iron deficiency anemia (IDA). NDA 208171, held by Pharmacosmos. Ferric Derisomaltose.
As of Nov 15, 2026, NDA 208171 (Monoferric), held by Pharmacosmos, was first approved by FDA on Jan 16, 2020, with 4 approved supplements and 0 published complete response letters.
Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis-dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product
| Oct 23, 2026 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jan 16, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Monoferric100MG/ML (100MG/ML) · solution;intravenous | Ferric Derisomaltose | DiscontinuedReference drug |
| Monoferric500MG/5ML (100MG/ML) · solution;intravenous | Ferric Derisomaltose | DiscontinuedReference drug |
| Monoferric1GM/10ML (100MG/ML) · solution;intravenous | Ferric Derisomaltose | RxReference drug |
| Oct 23, 2026 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 1, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Aug 4, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Sep 11, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Jan 16, 2020 | Original applicationNew formulation or manufacturer · 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
