APPLICATION
NDA010787
TYPE
NDA
ORIGINAL APPROVAL
1957-04-25
LATEST ACTION
1991-09-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
IRON DEXTRANDiscontinued
IRON DEXTRAN EQ 50MG IRON/ML · INJECTABLE · INJECTION
Approval history
1991-09-19Manufacturing (CMC) · Supplement 32 · priorityAP
1989-03-06Manufacturing (CMC) · Supplement 28 · priorityAP
1988-07-25Manufacturing (CMC) · Supplement 25 · priorityAP
1987-08-27Manufacturing (CMC) · Supplement 24 · priorityAP
1986-04-23Labeling · Supplement 23 · priorityAP
1984-11-20Manufacturing (CMC) · Supplement 22 · priorityAP
1983-12-20Labeling · Supplement 21 · priorityAP
1982-12-29Labeling · Supplement 19 · priorityAP
1982-08-18Manufacturing (CMC) · Supplement 16 · priorityAP
1982-06-23Labeling · Supplement 17 · priorityAP
1981-09-04Manufacturing (CMC) · Supplement 15 · priorityAP
1981-02-02Manufacturing (CMC) · Supplement 14 · priorityAP
1981-01-06REMS · Supplement 9 · priorityAP
1980-03-13Labeling · Supplement 13 · priorityAP
1976-11-12Labeling · Supplement 12 · priorityAP
1976-11-04Manufacturing (CMC) · Supplement 11 · priorityAP
1975-11-18Manufacturing (CMC) · Supplement 10 · priorityAP
1957-04-25Type 2 - New Active Ingredient · 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.
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