← FDA DRUG APPROVALS

FDA NDA · NDA021135

VENOFER

iron sucrose

Sponsor: AM REGENT

APPLICATION
NDA021135
TYPE
NDA
ORIGINAL APPROVAL
2000-11-06
LATEST ACTION
2026-03-02
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

VENOFERDiscontinued
IRON SUCROSE EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
VENOFERDiscontinued
IRON SUCROSE EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
VENOFER · ReferencePrescription
IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
VENOFER · ReferencePrescription
IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
VENOFER · ReferencePrescription
IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-03-02Manufacturing (CMC) · Supplement 42 — Label ↗AP
2024-08-01Labeling · Supplement 38 · standard — Label ↗AP
2021-01-20Labeling · Supplement 37 · standard — Letter ↗AP
2020-09-11Labeling · Supplement 36 · standard — Letter ↗AP
2018-12-19Labeling · Supplement 35 · standard — Label ↗AP
2017-11-28Labeling · Supplement 32 · standard — Label ↗AP
2016-06-13Manufacturing (CMC) · Supplement 29 · standardAP
2016-05-27Manufacturing (CMC) · Supplement 31 · standardAP
2016-03-02Manufacturing (CMC) · Supplement 26 · standardAP
2015-05-13Manufacturing (CMC) · Supplement 28 · standardAP
2014-06-13Manufacturing (CMC) · Supplement 27 · standardAP
2013-03-29Manufacturing (CMC) · Supplement 23 · standard — Label ↗AP
2012-09-21Efficacy · Supplement 24 · standard — Pediatric Medical Review ↗AP
2011-06-22Labeling · Supplement 20 · standard — Label ↗AP
2007-12-03Labeling · Supplement 17 · standard — Letter ↗AP
2007-02-09Manufacturing (CMC) · Supplement 15 — Label ↗AP
2005-10-17Efficacy · Supplement 13 · unknown — Label ↗AP
2005-06-17Efficacy · Supplement 8 · standard — Review ↗AP
2005-03-29Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2003-06-02Efficacy · Supplement 6 · standard — Letter ↗AP
2002-12-05Manufacturing (CMC) · Supplement 3 · standardAP
2002-07-26Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2002-01-22Manufacturing (CMC) · Supplement 2 · standardAP
2001-02-13Labeling · Supplement 1 · standardAP
2000-11-06Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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