APPLICATION
NDA016455
TYPE
NDA
ORIGINAL APPROVAL
1969-07-29
LATEST ACTION
2017-01-13
ROUTE
TOPICAL
DOSAGE FORM
TAPE
MARKETING STATUS
Prescription
Products
CORDRAN · ReferencePrescription
FLURANDRENOLIDE 0.004MG/SQ CM · TAPE · TOPICAL
Approval history
2017-01-13Manufacturing (CMC) · Supplement 25 · standardAP
2010-12-22Manufacturing (CMC) · Supplement 24AP
2000-07-19Manufacturing (CMC) · Supplement 19 · standardAP
1998-11-06Manufacturing (CMC) · Supplement 18 · standardAP
1997-12-23Manufacturing (CMC) · Supplement 17 · standardAP
1987-12-18Manufacturing (CMC) · Supplement 16 · standardAP
1987-08-19Manufacturing (CMC) · Supplement 14 · standardAP
1987-06-03Manufacturing (CMC) · Supplement 15 · standardAP
1985-12-20Manufacturing (CMC) · Supplement 13 · standardAP
1982-08-06Labeling · Supplement 12AP
1980-11-14Manufacturing (CMC) · Supplement 11 · standardAP
1977-10-19Manufacturing (CMC) · Supplement 9 · standardAP
1969-07-29Type 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.