APPLICATION
NDA016909
TYPE
NDA
ORIGINAL APPROVAL
1971-09-22
LATEST ACTION
2016-06-08
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
LIDEX · ReferenceDiscontinued
FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
Approval history
2000-09-26Manufacturing (CMC) · Supplement 47 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 46 · standardAP
1992-11-16Manufacturing (CMC) · Supplement 45 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 44 · standardAP
1991-03-12Labeling · Supplement 43AP
1990-02-13Manufacturing (CMC) · Supplement 42 · standardAP
1989-12-06Manufacturing (CMC) · Supplement 41 · standardAP
1989-09-26Manufacturing (CMC) · Supplement 40 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 39 · standardAP
1984-08-29Manufacturing (CMC) · Supplement 38 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 37 · standardAP
1983-09-07Manufacturing (CMC) · Supplement 36 · standardAP
1983-04-21Labeling · Supplement 35AP
1982-11-19Manufacturing (CMC) · Supplement 33 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 32 · standardAP
1981-11-10Manufacturing (CMC) · Supplement 31 · standardAP
1981-03-24Manufacturing (CMC) · Supplement 25 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 28 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 30 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 29 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 27 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 26 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 24 · standardAP
1979-08-13Manufacturing (CMC) · Supplement 23 · standardAP
1979-01-02Labeling · Supplement 20AP
1978-11-30Manufacturing (CMC) · Supplement 19 · standardAP
1978-11-29Manufacturing (CMC) · Supplement 21 · standardAP
1978-11-07Manufacturing (CMC) · Supplement 22 · standardAP
1978-07-05Manufacturing (CMC) · Supplement 18 · standardAP
1978-04-11Manufacturing (CMC) · Supplement 17 · standardAP
1977-12-14Manufacturing (CMC) · Supplement 16 · standardAP
1977-06-04Manufacturing (CMC) · Supplement 15 · standardAP
1977-01-11Labeling · Supplement 14AP
1971-09-22Type 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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