APPLICATION
NDA017373
TYPE
NDA
ORIGINAL APPROVAL
1973-05-15
LATEST ACTION
2005-12-16
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued
Products
FLUOCINONIDE · ReferenceDiscontinued
FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL
Approval history
2000-09-26Manufacturing (CMC) · Supplement 35 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 34 · standardAP
1992-11-16Manufacturing (CMC) · Supplement 33 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 32 · standardAP
1991-03-12Labeling · Supplement 31AP
1990-02-13Manufacturing (CMC) · Supplement 30 · standardAP
1989-12-06Manufacturing (CMC) · Supplement 29 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 28 · standardAP
1985-04-10Labeling · Supplement 27AP
1984-08-29Manufacturing (CMC) · Supplement 26 · standardAP
1983-12-06Manufacturing (CMC) · Supplement 24 · standardAP
1983-09-07Manufacturing (CMC) · Supplement 25 · standardAP
1983-04-21Labeling · Supplement 23AP
1982-11-19Manufacturing (CMC) · Supplement 21 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 20 · standardAP
1981-11-10Manufacturing (CMC) · Supplement 19 · standardAP
1981-11-03Manufacturing (CMC) · Supplement 18 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 16 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 17 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 15 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 14 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 13 · standardAP
1979-08-13Manufacturing (CMC) · Supplement 12 · standardAP
1978-11-29Manufacturing (CMC) · Supplement 11 · standardAP
1978-10-13Labeling · Supplement 9AP
1978-09-12Labeling · Supplement 10AP
1978-07-05Manufacturing (CMC) · Supplement 8 · standardAP
1977-12-14Manufacturing (CMC) · Supplement 7 · standardAP
1977-06-04Manufacturing (CMC) · Supplement 6 · standardAP
1977-01-04Labeling · Supplement 5AP
1976-01-23Labeling · Supplement 4AP
1973-05-15Type 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.
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