Dendrid

As of Nov 14, 2026, NDA 14169 (Dendrid), held by Alcon, was first approved by FDA on Jun 28, 1963, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1963
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 28, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dendrid0.1% · solution/drops;ophthalmic	Idoxuridine	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Jul 26, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 9, 1985	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 30, 1979	Supplement 10Labeling	Approved	None posted
Aug 22, 1977	Supplement 9Manufacturing · Standard review	Approved	None posted
May 11, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 28, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 14169
Drugs@FDA: Overview at FDA
Company: Alcon

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