APPLICATION
NDA016908
TYPE
NDA
ORIGINAL APPROVAL
1971-06-30
LATEST ACTION
2005-12-16
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
LIDEX · ReferenceDiscontinued
FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
LIDEX-E · ReferenceDiscontinued
FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
2000-09-26Manufacturing (CMC) · Supplement 55 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 54 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 53 · standardAP
1995-03-03Labeling · Supplement 49AP
1995-03-01Labeling · Supplement 52 · standardAP
1992-11-13Manufacturing (CMC) · Supplement 51 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 50 · standardAP
1990-02-13Manufacturing (CMC) · Supplement 48 · standardAP
1989-12-06Manufacturing (CMC) · Supplement 47 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 46 · standardAP
1984-08-29Manufacturing (CMC) · Supplement 45 · standardAP
1983-09-07Manufacturing (CMC) · Supplement 44 · standardAP
1983-04-08Labeling · Supplement 43AP
1982-11-19Manufacturing (CMC) · Supplement 41 · standardAP
1982-05-19Manufacturing (CMC) · Supplement 40 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 39 · standardAP
1981-11-16Manufacturing (CMC) · Supplement 38 · standardAP
1981-10-23Labeling · Supplement 27AP
1981-06-26Manufacturing (CMC) · Supplement 33 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 37 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 35 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 36 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 34 · standardAP
1979-12-18Manufacturing (CMC) · Supplement 30 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 29 · standardAP
1979-08-13Manufacturing (CMC) · Supplement 28 · standardAP
1978-11-29Manufacturing (CMC) · Supplement 26 · standardAP
1978-11-01Labeling · Supplement 25AP
1978-10-12Labeling · Supplement 24AP
1978-09-12Labeling · Supplement 23AP
1978-07-05Manufacturing (CMC) · Supplement 22 · standardAP
1978-04-11Manufacturing (CMC) · Supplement 21 · standardAP
1977-12-14Manufacturing (CMC) · Supplement 20 · standardAP
1977-09-19Manufacturing (CMC) · Supplement 18 · standardAP
1977-06-04Manufacturing (CMC) · Supplement 19 · standardAP
1977-01-04Labeling · Supplement 17AP
1976-05-06Manufacturing (CMC) · Supplement 16 · standardAP
1976-02-24Supplement · Supplement 15 · standardAP
1971-06-30Type 1 - New Molecular Entity · 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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