APPLICATION
NDA016161
TYPE
NDA
ORIGINAL APPROVAL
1967-07-25
LATEST ACTION
1994-10-24
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
SYNALAR-HPDiscontinued
FLUOCINOLONE ACETONIDE 0.2% · CREAM · TOPICAL
Approval history
1994-10-24Labeling · Supplement 42AP
1992-11-13Manufacturing (CMC) · Supplement 43 · standardAP
1992-04-24Manufacturing (CMC) · Supplement 41 · standardAP
1990-02-13Manufacturing (CMC) · Supplement 40 · standardAP
1989-02-10Manufacturing (CMC) · Supplement 39 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 38 · standardAP
1984-08-29Manufacturing (CMC) · Supplement 37 · standardAP
1983-09-07Manufacturing (CMC) · Supplement 36 · standardAP
1982-11-19Manufacturing (CMC) · Supplement 33 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 32 · standardAP
1981-11-10Manufacturing (CMC) · Supplement 31 · standardAP
1981-03-18Labeling · Supplement 30AP
1981-01-19Manufacturing (CMC) · Supplement 29 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 27 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 28 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 26 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 25 · standardAP
1979-08-13Manufacturing (CMC) · Supplement 24 · standardAP
1978-11-28Manufacturing (CMC) · Supplement 23 · standardAP
1978-09-12Labeling · Supplement 22AP
1978-06-30Manufacturing (CMC) · Supplement 21 · standardAP
1977-12-14Manufacturing (CMC) · Supplement 20 · standardAP
1977-06-04Manufacturing (CMC) · Supplement 17 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 19 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 18 · standardAP
1977-01-04Labeling · Supplement 16AP
1967-07-25Type 5 - New Formulation or New Manufacturer · 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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