APPLICATION
NDA017433
TYPE
NDA
ORIGINAL APPROVAL
1978-10-12
LATEST ACTION
1992-05-07
ROUTE
TOPICAL
DOSAGE FORM
SPONGE
MARKETING STATUS
Prescription
Products
PRE-OP II · ReferencePrescription
HEXACHLOROPHENE 480MG · SPONGE · TOPICAL
PRE-OP · ReferencePrescription
HEXACHLOROPHENE 480MG · SPONGE · TOPICAL
Approval history
1992-05-07Manufacturing (CMC) · Supplement 16 · standardAP
1992-04-01Manufacturing (CMC) · Supplement 15 · standardAP
1989-11-28Manufacturing (CMC) · Supplement 14 · standardAP
1985-08-30Manufacturing (CMC) · Supplement 13 · standardAP
1985-07-23Manufacturing (CMC) · Supplement 12 · standardAP
1985-03-25Manufacturing (CMC) · Supplement 11 · standardAP
1985-02-05Manufacturing (CMC) · Supplement 10 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 8 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 9 · standardAP
1982-11-29Manufacturing (CMC) · Supplement 7 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 6 · standardAP
1980-12-01Manufacturing (CMC) · Supplement 5 · standardAP
1980-12-01Manufacturing (CMC) · Supplement 1 · standardAP
1980-08-26Manufacturing (CMC) · Supplement 4 · standardAP
1980-02-11Labeling · Supplement 2AP
1978-10-12Type 5 - New Formulation or New Manufacturer · 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.