Kenalog

ANDA 84343, held by Delcor Asset Corp. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 84343 (Kenalog), held by Delcor Asset Corp, was first approved by FDA on Jul 16, 1974, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 16, 1974
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
Jul 16, 1974	Original application	Approved	None posted

Products

2 strengths and forms


Kenalog0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · lotion;topical	Triamcinolone Acetonide	Discontinued
Kenalog0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · lotion;topical	Triamcinolone Acetonide	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 9, 1992	Supplement 31Manufacturing	Approved	None posted
Jun 28, 1983	Supplement 25Manufacturing	Approved	None posted
May 5, 1983	Supplement 24Manufacturing	Approved	None posted
Dec 1, 1982	Supplement 23Manufacturing	Approved	None posted
Jun 21, 1982	Supplement 22Manufacturing	Approved	None posted
Dec 21, 1981	Supplement 17Manufacturing	Approved	None posted
Dec 21, 1981	Supplement 18Manufacturing	Approved	None posted
Dec 21, 1981	Supplement 21Manufacturing	Approved	None posted
Jul 16, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84343
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