Treats iron deficiency anemia (IDA). NDA 21135, held by Am Regent. Iron Sucrose.
As of Nov 14, 2026, NDA 21135 (Venofer), held by Am Regent, was first approved by FDA on Nov 6, 2000, with 24 approved supplements and 0 published complete response letters.
Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
| Sep 21, 2012 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2005 | Supplement 13Efficacy (new indication or use) | Approved | |
| Jun 17, 2005 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jun 2, 2003 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Nov 6, 2000 | Original applicationNew dosage form · Standard review | Approved |
| VenoferEQ 100MG IRON/5ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | RxReference drug |
| VenoferEQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | RxReference drug |
| VenoferEQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | Discontinued |
| VenoferEQ 200MG IRON/10ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | RxReference drug |
| VenoferEQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | Discontinued |
| Mar 2, 2026 | Supplement 42Manufacturing | Approved | |
| Aug 1, 2024 | Supplement 38Labeling · Standard review | Approved | |
| Jan 20, 2021 | Supplement 37Labeling · Standard review | Approved | |
| Sep 11, 2020 | Supplement 36Labeling · Standard review | Approved | |
| Dec 19, 2018 | Supplement 35Labeling · Standard review | Approved | |
| Nov 28, 2017 | Supplement 32Labeling · Standard review | Approved | |
| Jun 13, 2016 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| May 27, 2016 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 2, 2016 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 13, 2015 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jun 13, 2014 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 29, 2013 | Supplement 23Manufacturing · Standard review | Approved | |
| Sep 21, 2012 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2011 | Supplement 20Labeling · Standard review | Approved | |
| Dec 3, 2007 | Supplement 17Labeling · Standard review | Approved | |
| Feb 9, 2007 | Supplement 15Manufacturing | Approved | |
| Oct 17, 2005 | Supplement 13Efficacy (new indication or use) | Approved | |
| Jun 17, 2005 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 29, 2005 | Supplement 10Manufacturing · Standard review | Approved | |
| Jun 2, 2003 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 5, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 26, 2002 | Supplement 5Manufacturing · Standard review | Approved | |
| Jan 22, 2002 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 13, 2001 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 6, 2000 | Original applicationNew dosage form · 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
