NDA 40024, held by Am Regent. Iron Dextran.
As of Nov 13, 2026, NDA 40024 (Dexferrum), held by Am Regent, was first approved by FDA on Feb 23, 1996, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| DexferrumEQ 50MG IRON/ML · injectable;injection | Iron Dextran | Discontinued |
| Nov 18, 2016 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 12, 2009 | Supplement 22Labeling · Standard review | Approved | |
| Feb 8, 2002 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 31, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Jul 20, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Jul 20, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Feb 18, 2000 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 25, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Sep 25, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Sep 25, 1998 | Supplement 6Manufacturing | Approved | None posted |
| Sep 25, 1998 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 29, 1998 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 29, 1998 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 19, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Feb 23, 1996 | Original application | Approved | None posted |
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
