APPLICATION
NDA017807
TYPE
NDA
ORIGINAL APPROVAL
1981-03-26
LATEST ACTION
1989-03-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROFERDEXDiscontinued
IRON DEXTRAN EQ 50MG IRON/ML · INJECTABLE · INJECTION
Approval history
1989-03-06Manufacturing (CMC) · Supplement 7 · standardAP
1986-10-31Manufacturing (CMC) · Supplement 6 · standardAP
1986-04-17Labeling · Supplement 3AP
1984-11-19Manufacturing (CMC) · Supplement 4 · standardAP
1984-10-03Manufacturing (CMC) · Supplement 5 · standardAP
1984-01-04Manufacturing (CMC) · Supplement 2 · standardAP
1982-11-05Labeling · Supplement 1AP
1981-03-26Type 5 - New Formulation or New Manufacturer · Original · standardAP
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.