APPLICATION
NDA011283
TYPE
NDA
ORIGINAL APPROVAL
1958-01-14
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KENACORTDiscontinued
TRIAMCINOLONE 1MG · TABLET · ORAL
KENACORTDiscontinued
TRIAMCINOLONE 2MG · TABLET · ORAL
KENACORTDiscontinued
TRIAMCINOLONE 4MG · TABLET · ORAL
KENACORTDiscontinued
TRIAMCINOLONE 8MG · TABLET · ORAL
Approval history
2007-12-07Labeling · Supplement 42AP
2007-12-07Labeling · Supplement 34AP
2007-12-07Labeling · Supplement 39AP
2007-12-07Labeling · Supplement 35AP
1993-09-07Labeling · Supplement 44AP
1987-11-30Manufacturing (CMC) · Supplement 43 · standardAP
1979-08-21Manufacturing (CMC) · Supplement 40 · standardAP
1979-07-17Manufacturing (CMC) · Supplement 37 · standardAP
1979-07-17Labeling · Supplement 33AP
1979-06-04Labeling · Supplement 38AP
1968-07-19Supplement · Supplement 3 · standardAP
1958-01-14Type 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.
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.