Iron Dextran

Treats documented iron deficiency. Sold as Iron Dextran, Infed, Proferdex, Dexferrum. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 4 applications for Iron Dextran (sold as Iron Dextran, Infed, Proferdex and others), first approved Apr 25, 1957, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 25, 1957
Applications: 4
New uses approved: 0
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

INFED 100 MG/2 ML VIAL: $18.93 per MLBrand · +5% in a year

Clinical Trials

31 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's DiseaseCrohn's Disease, Iron Deficiency Anemia · Weill Medical College of Cornell University	Phase 4	Recruiting	Nov 9, 2026
Iron Repletion in Cystic FibrosisCystic Fibrosis, Iron Deficiencies · University of Michigan	Phase 4	Not yet recruiting	Oct 29, 2026
Nutritional Optimization in Anemic Patients Scheduled for Elective Open-Heart SurgeryAnemia, Iron Deficiency · National Institute of Cardiovascular Diseases, Pakistan	Phase 3	Not yet recruiting	Sep 3, 2026
The Effects and Neural Mechanisms of Vitamin D and Iron-Immune Homeostasis on Inhibitory Control in Obsessive-Compulsive DisorderObsessive Compulsive Disorder (OCD) · Guangdong Provincial People's Hospital	Not applicable	Enrolling by invitation	Aug 13, 2026
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.Anemia · Ain Shams University	Phase 2	Not yet recruiting	Jul 20, 2026
An RCT Study Between WHO and RCOG Based PracticesPostpartum Anemia · Sana Nadeem Qasir	Not applicable	Not yet recruiting	Jul 16, 2026
A Phase 1 Study of PVT401 in Healthy SubjectsInflammatory Bowel Disease (IBD) · Parvus Therapeutics, Inc.	Phase 1	Recruiting	Feb 20, 2026
The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency DepartmentIron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes · Children's Hospital of Orange County	Phase 4	Not yet recruiting	Feb 17, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 25, 1957	Iron DextranNDA 10787 · New active ingredient	Sanofi Aventis US	17	Discontinued
Apr 29, 1974	InfedNDA 17441 · New formulation or manufacturer	Allergan	145	Marketed
Mar 26, 1981	ProferdexNDA 17807 · New formulation or manufacturer	New River	7	Discontinued
Feb 23, 1996	DexferrumNDA 40024	Am Regent	14	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA