APPLICATION
NDA018234
TYPE
NDA
ORIGINAL APPROVAL
1980-01-24
LATEST ACTION
2004-09-29
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
HALOG-EDiscontinued
HALCINONIDE 0.1% · CREAM · TOPICAL
Approval history
1990-07-17Manufacturing (CMC) · Supplement 19 · standardAP
1989-06-27Manufacturing (CMC) · Supplement 18 · standardAP
1988-06-06Manufacturing (CMC) · Supplement 17 · standardAP
1986-10-24Manufacturing (CMC) · Supplement 15 · standardAP
1986-08-26Manufacturing (CMC) · Supplement 16 · standardAP
1986-05-27Manufacturing (CMC) · Supplement 14 · standardAP
1986-03-11Manufacturing (CMC) · Supplement 13 · standardAP
1985-07-29Manufacturing (CMC) · Supplement 12 · standardAP
1985-01-28Manufacturing (CMC) · Supplement 11 · standardAP
1985-01-16Manufacturing (CMC) · Supplement 10 · standardAP
1984-08-03Labeling · Supplement 9AP
1983-08-19Manufacturing (CMC) · Supplement 8 · standardAP
1983-08-05Manufacturing (CMC) · Supplement 7 · standardAP
1982-12-13Labeling · Supplement 6AP
1981-06-22Manufacturing (CMC) · Supplement 5 · standardAP
1980-07-21Manufacturing (CMC) · Supplement 4 · standardAP
1980-06-20Manufacturing (CMC) · Supplement 3 · standardAP
1980-04-15Manufacturing (CMC) · Supplement 2 · standardAP
1980-04-03Manufacturing (CMC) · Supplement 1 · standardAP
1980-01-24Type 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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