APPLICATION
NDA016729
TYPE
NDA
ORIGINAL APPROVAL
1973-12-17
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FERROUS CITRATE FE 59Discontinued
FERROUS CITRATE, FE-59 25uCi/ML · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 6AP
1984-05-24Labeling · Supplement 9AP
1982-05-10Manufacturing (CMC) · Supplement 7 · priorityAP
1977-08-23Manufacturing (CMC) · Supplement 4 · priorityAP
1977-07-27Manufacturing (CMC) · Supplement 3 · priorityAP
1973-12-17Type 1 - New Molecular Entity · Original · priorityAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.