APPLICATION
NDA017001
TYPE
NDA
ORIGINAL APPROVAL
1971-11-26
LATEST ACTION
2022-02-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ANCOBON · ReferencePrescription
FLUCYTOSINE 500MG · CAPSULE · ORAL
ANCOBON · ReferencePrescription
FLUCYTOSINE 250MG · CAPSULE · ORAL
Approval history
2016-02-05Manufacturing (CMC) · Supplement 31 · priorityAP
2014-01-08Manufacturing (CMC) · Supplement 30 · priorityAP
2000-02-03Manufacturing (CMC) · Supplement 24 · priorityAP
1999-09-29Manufacturing (CMC) · Supplement 23 · priorityAP
1997-08-27Manufacturing (CMC) · Supplement 22 · priorityAP
1997-07-31Manufacturing (CMC) · Supplement 21 · priorityAP
1987-06-01Labeling · Supplement 13AP
1984-08-08Manufacturing (CMC) · Supplement 17 · priorityAP
1983-12-21Manufacturing (CMC) · Supplement 16 · priorityAP
1982-12-06Manufacturing (CMC) · Supplement 15 · priorityAP
1982-01-27Manufacturing (CMC) · Supplement 14 · priorityAP
1981-04-23Manufacturing (CMC) · Supplement 12 · priorityAP
1979-11-26Manufacturing (CMC) · Supplement 11 · priorityAP
1978-08-24Manufacturing (CMC) · Supplement 10 · priorityAP
1978-01-03Manufacturing (CMC) · Supplement 9 · priorityAP
1977-08-11Manufacturing (CMC) · Supplement 8 · priorityAP
1977-05-13Manufacturing (CMC) · Supplement 7 · priorityAP
1971-11-26Type 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.