APPLICATION
NDA015296
TYPE
NDA
ORIGINAL APPROVAL
1964-05-27
LATEST ACTION
2012-11-19
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SYNALAR · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.01% · SOLUTION · TOPICAL
Approval history
2012-11-16Manufacturing (CMC) · Supplement 63 · standardAP
2000-09-26Manufacturing (CMC) · Supplement 58 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 57 · standardAP
1995-03-06Labeling · Supplement 53AP
1995-03-02Labeling · Supplement 56 · standardAP
1992-11-13Manufacturing (CMC) · Supplement 55 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 54 · standardAP
1990-02-13Manufacturing (CMC) · Supplement 52 · standardAP
1989-12-19Manufacturing (CMC) · Supplement 51 · standardAP
1989-12-19Manufacturing (CMC) · Supplement 49 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 48 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 47 · standardAP
1984-08-29Manufacturing (CMC) · Supplement 46 · standardAP
1983-09-07Manufacturing (CMC) · Supplement 45 · standardAP
1983-06-23Labeling · Supplement 44AP
1982-11-19Manufacturing (CMC) · Supplement 42 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 41 · standardAP
1981-11-16Manufacturing (CMC) · Supplement 40 · standardAP
1981-06-03Manufacturing (CMC) · Supplement 35 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 37 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 38 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 36 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 39 · standardAP
1980-02-19Labeling · Supplement 34AP
1979-10-23Manufacturing (CMC) · Supplement 33 · standardAP
1979-08-13Manufacturing (CMC) · Supplement 32 · standardAP
1979-03-14Manufacturing (CMC) · Supplement 29 · standardAP
1979-02-28Labeling · Supplement 30AP
1978-11-28Manufacturing (CMC) · Supplement 31 · standardAP
1978-06-30Manufacturing (CMC) · Supplement 28 · standardAP
1978-01-09Manufacturing (CMC) · Supplement 26 · standardAP
1977-06-04Manufacturing (CMC) · Supplement 23 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 25 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 24 · standardAP
1976-10-12Labeling · Supplement 21AP
1976-01-07Manufacturing (CMC) · Supplement 20 · standardAP
1964-05-27Type 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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