APPLICATION
ANDA206550
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-17
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLUCYTOSINEDiscontinued
FLUCYTOSINE 500MG · CAPSULE · ORAL
FLUCYTOSINEDiscontinued
FLUCYTOSINE 250MG · CAPSULE · ORAL
Approval history
2025-02-18Labeling · Supplement 2 · standardAP
2025-02-18Labeling · Supplement 3 · standardAP
2025-02-18Labeling · Supplement 1 · standardAP
2017-10-17UNKNOWN · 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.