APPLICATION
NDA012787
TYPE
NDA
ORIGINAL APPROVAL
1963-02-15
LATEST ACTION
2013-03-28
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
SYNALAR · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.01% · CREAM · TOPICAL
SYNALAR · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.025% · CREAM · TOPICAL
SYNALAR · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.025% · CREAM · TOPICAL
Approval history
2000-09-26Manufacturing (CMC) · Supplement 66 · priorityAP
1996-07-22Manufacturing (CMC) · Supplement 65 · priorityAP
1995-03-06Labeling · Supplement 60AP
1995-03-06Labeling · Supplement 61AP
1995-03-01Labeling · Supplement 64 · standardAP
1992-11-13Manufacturing (CMC) · Supplement 63 · priorityAP
1992-04-24Manufacturing (CMC) · Supplement 62 · priorityAP
1990-02-13Manufacturing (CMC) · Supplement 59 · priorityAP
1989-04-12Manufacturing (CMC) · Supplement 56 · priorityAP
1989-04-04Manufacturing (CMC) · Supplement 58 · priorityAP
1989-02-10Manufacturing (CMC) · Supplement 57 · priorityAP
1984-12-20Manufacturing (CMC) · Supplement 55 · priorityAP
1984-08-29Manufacturing (CMC) · Supplement 54 · priorityAP
1983-09-07Manufacturing (CMC) · Supplement 53 · priorityAP
1983-04-08Labeling · Supplement 52AP
1982-11-19Manufacturing (CMC) · Supplement 50 · priorityAP
1981-11-20Manufacturing (CMC) · Supplement 49 · priorityAP
1981-11-12Manufacturing (CMC) · Supplement 48 · priorityAP
1981-06-26Manufacturing (CMC) · Supplement 43 · priorityAP
1981-01-19Manufacturing (CMC) · Supplement 46 · priorityAP
1981-01-19Manufacturing (CMC) · Supplement 44 · priorityAP
1981-01-19Manufacturing (CMC) · Supplement 47 · priorityAP
1981-01-19Manufacturing (CMC) · Supplement 45 · priorityAP
1980-07-30Manufacturing (CMC) · Supplement 42 · priorityAP
1980-02-19Labeling · Supplement 40AP
1980-02-19Labeling · Supplement 39AP
1979-10-23Manufacturing (CMC) · Supplement 38 · priorityAP
1979-08-13Manufacturing (CMC) · Supplement 37 · priorityAP
1979-07-25Manufacturing (CMC) · Supplement 36 · priorityAP
1979-04-13Manufacturing (CMC) · Supplement 34 · priorityAP
1979-01-10Labeling · Supplement 31AP
1978-11-28Manufacturing (CMC) · Supplement 33 · priorityAP
1978-09-12Labeling · Supplement 32AP
1977-06-04Manufacturing (CMC) · Supplement 30 · priorityAP
1977-01-04Labeling · Supplement 29AP
1976-07-08Labeling · Supplement 28AP
1975-12-12Labeling · Supplement 27AP
1975-06-26Labeling · Supplement 26AP
1963-02-15Type 1 - New Molecular Entity · Original · priorityAP
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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