APPLICATION
NDA012097
TYPE
NDA
ORIGINAL APPROVAL
1960-03-04
LATEST ACTION
2002-09-03
ROUTE
DENTAL
DOSAGE FORM
PASTE
MARKETING STATUS
Discontinued
Products
KENALOG IN ORABASE · ReferenceDiscontinued
TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · PASTE · DENTAL
Approval history
1996-05-22Manufacturing (CMC) · Supplement 27 · standardAP
1993-11-19Manufacturing (CMC) · Supplement 26 · standardAP
1990-06-13Manufacturing (CMC) · Supplement 25 · standardAP
1988-07-11Manufacturing (CMC) · Supplement 24 · standardAP
1988-07-11Manufacturing (CMC) · Supplement 23 · standardAP
1987-11-30Manufacturing (CMC) · Supplement 20 · standardAP
1987-04-10Manufacturing (CMC) · Supplement 21 · standardAP
1986-11-19Manufacturing (CMC) · Supplement 19 · standardAP
1986-01-23Manufacturing (CMC) · Supplement 18 · standardAP
1983-08-11Manufacturing (CMC) · Supplement 17 · standardAP
1982-06-16Manufacturing (CMC) · Supplement 15 · standardAP
1979-08-21Manufacturing (CMC) · Supplement 14 · standardAP
1979-07-17Manufacturing (CMC) · Supplement 12 · standardAP
1978-02-22Labeling · Supplement 9AP
1977-05-09Manufacturing (CMC) · Supplement 7 · standardAP
1977-05-09Manufacturing (CMC) · Supplement 8 · standardAP
1977-02-08Labeling · Supplement 6AP
1960-03-04Type 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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