Visine L.R.

NDA 19407, held by Kenvue Brands. Oxymetazoline Hydrochloride.

As of Nov 13, 2026, NDA 19407 (Visine L.R.), held by Kenvue Brands, was first approved by FDA on Mar 31, 1989, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1989
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 31, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Visine L.R.0.025% · solution/drops;ophthalmic	Oxymetazoline Hydrochloride	OTCReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 1, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Jan 11, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 10, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 15, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 17, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 5, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 13, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 27, 1989	Supplement 1Labeling	Approved	None posted
Mar 31, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19407
Drugs@FDA: Overview at FDA
Company: Kenvue Brands

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