← FDA DRUG APPROVALS

FDA NDA · NDA014901

KENALOG-40

triamcinolone acetonide

Sponsor: APOTHECON

APPLICATION
NDA014901
TYPE
NDA
ORIGINAL APPROVAL
1965-02-01
LATEST ACTION
2024-08-09
ROUTE
INTRA-ARTICULAR, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KENALOG-40 · ReferencePrescription
TRIAMCINOLONE ACETONIDE 40MG/ML · INJECTABLE · INJECTION
KENALOG-80 · ReferencePrescription
TRIAMCINOLONE ACETONIDE 80MG/ML · INJECTABLE · INJECTION

Approval history

2024-08-09Manufacturing (CMC) · Supplement 55 — Label ↗AP
2024-06-05Labeling · Supplement 54 · standard — Label ↗AP
2019-04-12Manufacturing (CMC) · Supplement 47 · standard — Label ↗AP
2018-06-22Labeling · Supplement 45 · standard — Label ↗AP
2018-03-29Labeling · Supplement 44 · standard — Label ↗AP
2015-10-26Manufacturing (CMC) · Supplement 43 · standard — Review ↗AP
2014-07-03Labeling · Supplement 42 · standard — Letter ↗AP
2011-07-15Labeling · Supplement 39 · unknown — Letter ↗AP
2011-06-16Labeling · Supplement 38 · unknown — Letter ↗AP
2010-01-28Labeling · Supplement 37 · standard — Label ↗AP
2006-11-20Labeling · Supplement 34 · standard — Label ↗AP
2001-01-05Manufacturing (CMC) · Supplement 35 · standardAP
1996-05-22Manufacturing (CMC) · Supplement 33 · standardAP
1995-01-10Manufacturing (CMC) · Supplement 31 · standardAP
1994-03-28Manufacturing (CMC) · Supplement 30 · standardAP
1992-02-14Manufacturing (CMC) · Supplement 28 · standard — Review ↗AP
1991-07-19Manufacturing (CMC) · Supplement 29 · standard — Review ↗AP
1987-11-30Manufacturing (CMC) · Supplement 26 · standardAP
1986-11-19Manufacturing (CMC) · Supplement 27 · standardAP
1985-12-04Manufacturing (CMC) · Supplement 22 · standardAP
1985-06-14Labeling · Supplement 25AP
1984-04-13Manufacturing (CMC) · Supplement 24 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 21 · standardAP
1980-05-20Manufacturing (CMC) · Supplement 18 · standardAP
1979-08-21Manufacturing (CMC) · Supplement 19 · standardAP
1979-07-27Labeling · Supplement 9 — Review ↗AP
1979-07-17Manufacturing (CMC) · Supplement 17 · standardAP
1978-04-07Manufacturing (CMC) · Supplement 16 · standardAP
1978-04-07Labeling · Supplement 10 — Review ↗AP
1965-02-01Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →