Kenalog

NDA 12104, held by Sun Pharm Inds Inc. Triamcinolone Acetonide.

As of Nov 13, 2026, NDA 12104 (Kenalog), held by Sun Pharm Inds Inc, was first approved by FDA on Oct 11, 1974, with 24 approved supplements and 0 published complete response letters.

First approved: Oct 11, 1974
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Oct 11, 1974	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kenalog0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;topical	Triamcinolone Acetonide	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements


Jan 26, 2017	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 6, 2015	Supplement 36Manufacturing · Standard review	Approved	None posted
Nov 15, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Jun 21, 2013	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 1, 2011	Supplement 32Manufacturing · Standard review	Approved	Letter Label
Aug 20, 2009	Supplement 30Manufacturing	Approved	None posted
Oct 12, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 5, 1997	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 23, 1992	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 4, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 23, 1985	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 11, 1985	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 6, 1983	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 20, 1982	Supplement 21Labeling	Approved	None posted
Jul 21, 1980	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 2, 1979	Supplement 19Labeling	Approved	None posted
Mar 16, 1979	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 5, 1978	Supplement 17Labeling	Approved	None posted
Oct 11, 1977	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 11, 1977	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 23, 1977	Supplement 13Labeling	Approved	None posted
Feb 4, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 18, 1976	Supplement 11Labeling	Approved	None posted
Oct 11, 1974	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 11, 1974	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12104
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters