Kenacort

NDA 12515, held by Delcor Asset Corp. Triamcinolone Diacetate.

As of Nov 13, 2026, NDA 12515 (Kenacort), held by Delcor Asset Corp, was first approved by FDA on Mar 21, 1961, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 21, 1961
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 21, 1961	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
KenacortEQ 4MG BASE/5ML · syrup;oral	Triamcinolone Diacetate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 10Labeling	Approved	None posted
Mar 13, 2009	Supplement 16Labeling	Approved	None posted
Mar 13, 2009	Supplement 18Labeling	Approved	None posted
Sep 7, 1993	Supplement 21Labeling	Approved	None posted
Jun 30, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 21, 1979	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 17, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 2, 1978	Supplement 12Labeling	Approved	None posted
Mar 21, 1961	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12515
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