APPLICATION
NDA012041
TYPE
NDA
ORIGINAL APPROVAL
1960-01-04
LATEST ACTION
2024-08-14
ROUTE
INTRA-ARTICULAR, INTRALESIONAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KENALOG-10 · ReferencePrescription
TRIAMCINOLONE ACETONIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2015-10-26Manufacturing (CMC) · Supplement 43 · standardAP
2001-06-15Manufacturing (CMC) · Supplement 34 · standardAP
1998-02-03Manufacturing (CMC) · Supplement 32 · standardAP
1996-05-22Manufacturing (CMC) · Supplement 31 · standardAP
1995-01-10Manufacturing (CMC) · Supplement 30 · standardAP
1993-10-06Labeling · Supplement 27AP
1993-08-30Manufacturing (CMC) · Supplement 28 · standardAP
1993-08-30Manufacturing (CMC) · Supplement 29 · standardAP
1991-09-25Manufacturing (CMC) · Supplement 26 · standardAP
1991-07-19Manufacturing (CMC) · Supplement 25 · standardAP
1987-11-30Manufacturing (CMC) · Supplement 23 · standardAP
1986-11-19Manufacturing (CMC) · Supplement 24 · standardAP
1985-12-03Manufacturing (CMC) · Supplement 22 · standardAP
1982-01-12Labeling · Supplement 14AP
1981-04-01Manufacturing (CMC) · Supplement 21 · standardAP
1980-05-20Manufacturing (CMC) · Supplement 18 · standardAP
1979-08-21Manufacturing (CMC) · Supplement 19 · standardAP
1979-07-17Manufacturing (CMC) · Supplement 17 · standardAP
1978-12-28Labeling · Supplement 13AP
1977-09-19Manufacturing (CMC) · Supplement 16 · standardAP
1960-01-04Type 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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