APPLICATION
NDA013960
TYPE
NDA
ORIGINAL APPROVAL
1963-06-19
LATEST ACTION
2000-09-26
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
SYNALAR · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.025% · OINTMENT · TOPICAL
Approval history
2000-09-26Manufacturing (CMC) · Supplement 52 · standardAP
1995-03-02Labeling · Supplement 51 · standardAP
1995-03-02Labeling · Supplement 48AP
1992-11-13Manufacturing (CMC) · Supplement 50 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 49 · standardAP
1990-02-13Manufacturing (CMC) · Supplement 47 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 46 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 45 · standardAP
1984-08-29Manufacturing (CMC) · Supplement 44 · standardAP
1984-05-25Manufacturing (CMC) · Supplement 43 · standardAP
1983-04-08Labeling · Supplement 42AP
1982-11-19Manufacturing (CMC) · Supplement 40 · standardAP
1982-01-08Labeling · Supplement 37AP
1981-11-20Manufacturing (CMC) · Supplement 39 · standardAP
1981-11-16Manufacturing (CMC) · Supplement 38 · standardAP
1981-09-15Manufacturing (CMC) · Supplement 32 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 35 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 33 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 36 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 34 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 31 · standardAP
1980-02-19Labeling · Supplement 30AP
1979-10-23Manufacturing (CMC) · Supplement 29 · standardAP
1979-08-13Manufacturing (CMC) · Supplement 28 · standardAP
1979-01-02Labeling · Supplement 26AP
1978-11-28Manufacturing (CMC) · Supplement 27 · standardAP
1978-10-12Labeling · Supplement 25AP
1978-06-30Manufacturing (CMC) · Supplement 24 · standardAP
1978-01-09Manufacturing (CMC) · Supplement 23 · standardAP
1977-06-04Manufacturing (CMC) · Supplement 20 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 22 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 21 · standardAP
1977-01-04Labeling · Supplement 19AP
1976-07-15Labeling · Supplement 18AP
1975-07-16Labeling · Supplement 17AP
1963-06-19Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.