APPLICATION
NDA018423
TYPE
NDA
ORIGINAL APPROVAL
1981-08-27
LATEST ACTION
2001-12-12
ROUTE
TOPICAL
DOSAGE FORM
SPONGE
MARKETING STATUS
Discontinued
Products
HIBICLENS · ReferenceDiscontinued
CHLORHEXIDINE GLUCONATE 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPONGE · TOPICAL
Approval history
2001-12-12Manufacturing (CMC) · Supplement 16 · standardAP
1999-10-19Manufacturing (CMC) · Supplement 14 · standardAP
1992-07-23Manufacturing (CMC) · Supplement 13 · standardAP
1989-09-15Manufacturing (CMC) · Supplement 11 · standardAP
1989-08-25Labeling · Supplement 10AP
1989-07-14Manufacturing (CMC) · Supplement 12 · standardAP
1988-09-02Manufacturing (CMC) · Supplement 5 · standardAP
1988-07-05Manufacturing (CMC) · Supplement 8 · standardAP
1988-06-22Labeling · Supplement 7AP
1987-12-10Manufacturing (CMC) · Supplement 6 · standardAP
1986-02-22Manufacturing (CMC) · Supplement 3 · standardAP
1983-11-18Manufacturing (CMC) · Supplement 2 · standardAP
1981-10-19Manufacturing (CMC) · Supplement 1 · standardAP
1981-08-27Type 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.
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