Ocuclear

NDA 18471, held by Bayer Healthcare LLC. Oxymetazoline Hydrochloride.

As of Nov 13, 2026, NDA 18471 (Ocuclear), held by Bayer Healthcare LLC, was first approved by FDA on May 30, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: May 30, 1986
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 30, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ocuclear0.025% · solution/drops;ophthalmic	Oxymetazoline Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jun 6, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 24, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 14, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 13, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
May 16, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 24, 1989	Supplement 11Labeling	Approved	None posted
Jun 9, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 6, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 30, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 15, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 4, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 3, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
May 12, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 20, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
May 30, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18471
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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