Iopidine

NDA 19779, held by Harrow Eye. Apraclonidine Hydrochloride.

As of Nov 13, 2026, NDA 19779 (Iopidine), held by Harrow Eye, was first approved by FDA on Dec 31, 1987, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1987
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Dec 15, 1989	Supplement 4Efficacy (new indication or use)	Approved	None posted
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
IopidineEQ 1% BASE · solution/drops;ophthalmic	Apraclonidine Hydrochloride	RxReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 18, 2026	Supplement 28Labeling · Standard review	Approved	Label Letter
Mar 1, 2018	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 6, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Nov 5, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 15, 2004	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 15, 2004	Supplement 18Labeling · Standard review	Approved	Letter Label
May 15, 2003	Supplement 15Labeling · Standard review	Approved	Letter
Mar 22, 2002	Supplement 14Labeling · Standard review	Approved	Label Letter
Sep 21, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 13, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 3, 1997	Supplement 11Labeling · Standard review	Approved	None posted
Aug 27, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Aug 30, 1995	Supplement 9Labeling · Standard review	Approved	None posted
Aug 20, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 29, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
May 2, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 15, 1989	Supplement 4Efficacy (new indication or use)	Approved	None posted
Dec 11, 1989	Supplement 3Labeling	Approved	None posted
Mar 31, 1989	Supplement 1Labeling	Approved	None posted
Jan 3, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19779
Drugs@FDA: Overview at FDA
Company: Harrow Eye LLC

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