APPLICATION
NDA016929
TYPE
NDA
ORIGINAL APPROVAL
1970-12-18
LATEST ACTION
1999-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FUDR · ReferenceDiscontinued
FLOXURIDINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-09-20Manufacturing (CMC) · Supplement 27 · priorityAP
1997-09-15Manufacturing (CMC) · Supplement 26 · priorityAP
1992-10-19Manufacturing (CMC) · Supplement 25 · priorityAP
1990-08-22Labeling · Supplement 14AP
1990-07-30Manufacturing (CMC) · Supplement 23 · priorityAP
1990-07-12Manufacturing (CMC) · Supplement 24 · priorityAP
1990-05-14Labeling · Supplement 15AP
1989-03-20Manufacturing (CMC) · Supplement 22 · priorityAP
1988-04-12Manufacturing (CMC) · Supplement 21 · priorityAP
1987-06-01Labeling · Supplement 20AP
1987-01-15Labeling · Supplement 19AP
1987-01-09Manufacturing (CMC) · Supplement 18 · priorityAP
1985-09-23Manufacturing (CMC) · Supplement 17 · priorityAP
1984-04-04Manufacturing (CMC) · Supplement 16 · priorityAP
1978-04-07Labeling · Supplement 13AP
1978-01-09Manufacturing (CMC) · Supplement 12 · priorityAP
1977-09-15Manufacturing (CMC) · Supplement 11 · priorityAP
1977-02-23Manufacturing (CMC) · Supplement 9 · priorityAP
1976-02-25Manufacturing (CMC) · Supplement 8 · priorityAP
1976-02-25Manufacturing (CMC) · Supplement 6 · priorityAP
1970-12-18Type 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.