← FDA DRUG APPROVALS

FDA NDA · NDA017441

INFED

iron dextran

Sponsor: ALLERGAN

APPLICATION
NDA017441
TYPE
NDA
ORIGINAL APPROVAL
1974-04-29
LATEST ACTION
2024-08-01
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INFED · ReferencePrescription
IRON DEXTRAN EQ 100MG IRON/2ML (EQ 50MG IRON/ML) · INJECTABLE · INJECTION

Approval history

2024-08-01Labeling · Supplement 181 · standard — Label ↗AP
2021-09-14Labeling · Supplement 180 · standard — Letter ↗AP
2021-04-20Labeling · Supplement 179 · standard — Letter ↗AP
2020-09-11Labeling · Supplement 178 · standard — Letter ↗AP
2009-08-12Labeling · Supplement 171 · standard — Label ↗AP
2002-11-26Manufacturing (CMC) · Supplement 164 · priorityAP
2001-11-20Manufacturing (CMC) · Supplement 162 · priorityAP
2001-07-24Manufacturing (CMC) · Supplement 160 · priorityAP
2001-07-23Manufacturing (CMC) · Supplement 159 · priorityAP
2001-04-18Labeling · Supplement 161 · standard — Letter ↗AP
1999-09-13Manufacturing (CMC) · Supplement 158 · priorityAP
1999-04-15Manufacturing (CMC) · Supplement 157 · priorityAP
1999-01-13Manufacturing (CMC) · Supplement 154 · priorityAP
1999-01-13Manufacturing (CMC) · Supplement 155 · priorityAP
1998-05-22Manufacturing (CMC) · Supplement 153 · priorityAP
1997-04-04Labeling · Supplement 150 · standardAP
1997-04-04Labeling · Supplement 151 · standardAP
1997-02-21Manufacturing (CMC) · Supplement 152 · priorityAP
1995-08-11Manufacturing (CMC) · Supplement 149 · priorityAP
1994-04-13Labeling · Supplement 148 · standardAP
1994-04-12Manufacturing (CMC) · Supplement 146 · priorityAP
1992-04-22Manufacturing (CMC) · Supplement 145 · priorityAP
1991-08-05Labeling · Supplement 144AP
1991-07-12Manufacturing (CMC) · Supplement 142 · priorityAP
1991-07-12Labeling · Supplement 143AP
1991-07-12Manufacturing (CMC) · Supplement 141 · priorityAP
1988-01-12Labeling · Supplement 139AP
1986-04-07Manufacturing (CMC) · Supplement 138 · priorityAP
1985-05-13Labeling · Supplement 137AP
1981-06-17Labeling · Supplement 135AP
1981-06-15Labeling · Supplement 134AP
1981-06-15Labeling · Supplement 132AP
1981-06-15Labeling · Supplement 133AP
1981-03-05Labeling · Supplement 130AP
1981-03-05Labeling · Supplement 129AP
1981-02-18Labeling · Supplement 131AP
1981-02-03Labeling · Supplement 128AP
1981-01-16Labeling · Supplement 127AP
1980-08-20Labeling · Supplement 126AP
1980-08-20Labeling · Supplement 125AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →