Opcon-A

NDA 20065, held by Bausch And Lomb. Naphazoline Hydrochloride; Pheniramine Maleate.

As of Nov 13, 2026, NDA 20065 (Opcon-A), held by Bausch And Lomb, was first approved by FDA on Jun 8, 1994, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1994
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 8, 1994	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Opcon-A0.02675%;0.315% · solution/drops;ophthalmic	Naphazoline Hydrochloride; Pheniramine Maleate	OTCReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 23, 2022	Supplement 33Labeling · Standard review	Approved	Label Letter
Mar 14, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 18, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
May 12, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 31, 2007	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 20, 2005	Supplement 10Manufacturing · Standard review	Approved	Letter
Dec 18, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 23, 1996	Supplement 14Labeling · Standard review	Approved	None posted
Jul 23, 1996	Supplement 13Labeling · Standard review	Approved	None posted
May 9, 1996	Supplement 11Labeling · Standard review	Approved	None posted
Apr 11, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 13, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
May 11, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 29, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 29, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 11, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 8, 1994	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20065
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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