Iopidine

For apraclonidine ophthalmic solution 0.5%. NDA 20258, held by Harrow Eye. Apraclonidine Hydrochloride.

As of Nov 13, 2026, NDA 20258 (Iopidine), held by Harrow Eye, was first approved by FDA on Jul 30, 1993, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1993
Review: Priority
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 30, 1993	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
IopidineEQ 0.5% BASE · solution/drops;ophthalmic	Apraclonidine Hydrochloride	RxReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 18, 2026	Supplement 34Labeling · Standard review	Approved	Label Letter
Mar 1, 2018	Supplement 30Labeling · Standard review	Approved	Letter Label
Apr 6, 2017	Supplement 26Labeling · Standard review	Approved	Letter Label
May 9, 2003	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 4, 2002	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 13, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 21, 2001	Supplement 16Manufacturing · Priority review	Approved	None posted
Mar 16, 2001	Supplement 15Manufacturing · Priority review	Approved	None posted
Sep 13, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
May 16, 2000	Supplement 11Labeling · Standard review	Approved	None posted
Feb 18, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
Sep 28, 1999	Supplement 10Manufacturing · Priority review	Approved	None posted
Aug 17, 1999	Supplement 12Manufacturing · Priority review	Approved	None posted
Apr 7, 1999	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 11, 1999	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 5, 1999	Supplement 8Manufacturing · Priority review	Approved	None posted
Aug 4, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 15, 1998	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 9, 1997	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 17, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 1, 1995	Supplement 2Manufacturing · Priority review	Approved	None posted
Nov 1, 1995	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 30, 1993	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20258
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