APPLICATION
NDA012515
TYPE
NDA
ORIGINAL APPROVAL
1961-03-21
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
KENACORTDiscontinued
TRIAMCINOLONE DIACETATE EQ 4MG BASE/5ML · SYRUP · ORAL
Approval history
2009-03-13Labeling · Supplement 18AP
2009-03-13Labeling · Supplement 16AP
2009-03-13Labeling · Supplement 10AP
1993-09-07Labeling · Supplement 21AP
1982-06-30Manufacturing (CMC) · Supplement 19 · standardAP
1979-08-21Manufacturing (CMC) · Supplement 17 · standardAP
1979-07-17Manufacturing (CMC) · Supplement 15 · standardAP
1978-11-02Labeling · Supplement 12AP
1961-03-21Type 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.