Kenalog In Orabase

NDA 12097, held by Delcor Asset Corp. Triamcinolone Acetonide.

As of Nov 13, 2026, NDA 12097 (Kenalog In Orabase), held by Delcor Asset Corp, was first approved by FDA on Mar 4, 1960, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 4, 1960
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 4, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kenalog In Orabase0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · paste;dental	Triamcinolone Acetonide	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Sep 3, 2002	Supplement 16Labeling	Approved	Letter Label
May 22, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 19, 1993	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 13, 1990	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 11, 1988	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 11, 1988	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 30, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 10, 1987	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 19, 1986	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 23, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 11, 1983	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 16, 1982	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 21, 1979	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 17, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 22, 1978	Supplement 9Labeling	Approved	None posted
May 9, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
May 9, 1977	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 8, 1977	Supplement 6Labeling	Approved	None posted
Mar 4, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12097
Drugs@FDA: Overview at FDA
Company: Delcor Asset Corp.

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