APPLICATION
NDA050509
TYPE
NDA
ORIGINAL APPROVAL
1979-09-13
LATEST ACTION
1987-01-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCLAPEN-WDiscontinued
CYCLACILLIN 250MG · TABLET · ORAL
CYCLAPEN-WDiscontinued
CYCLACILLIN 500MG · TABLET · ORAL
Approval history
1987-01-20Manufacturing (CMC) · Supplement 5 · standardAP
1985-10-09Manufacturing (CMC) · Supplement 4 · standardAP
1985-08-12Manufacturing (CMC) · Supplement 3 · standardAP
1984-09-24Manufacturing (CMC) · Supplement 2 · standardAP
1984-02-13Manufacturing (CMC) · Supplement 1 · standardAP
1982-07-08Manufacturing (CMC) · Supplement 11 · standardAP
1982-03-08Labeling · Supplement 10 · standardAP
1980-04-30Manufacturing (CMC) · Supplement 9 · standardAP
1980-04-07Manufacturing (CMC) · Supplement 8 · standardAP
1979-10-30Manufacturing (CMC) · Supplement 7 · standardAP
1979-09-19Labeling · Supplement 6 · standardAP
1979-09-13Type 3 - New Dosage Form · 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.