Tridesilon

NDA 17914, held by Bayer Pharms. Acetic Acid, Glacial; Desonide.

As of Nov 14, 2026, NDA 17914 (Tridesilon), held by Bayer Pharms, was first approved by FDA on Feb 21, 1978, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 21, 1978
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 21, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tridesilon2%;0.05% · solution/drops;otic	Acetic Acid, Glacial; Desonide	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jul 25, 1997	Supplement 5Labeling	Approved	None posted
Mar 4, 1991	Supplement 8Labeling	Approved	None posted
Oct 17, 1988	Supplement 4Labeling	Approved	None posted
Feb 29, 1980	Supplement 2Labeling	Approved	None posted
Feb 21, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17914
Drugs@FDA: Overview at FDA
Company: Bayer Pharms

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