Latanoprost

Reduces elevated intraocular pressure (IOP). ANDA 201786, held by Somerset. Latanoprost.

As of Nov 15, 2026, ANDA 201786 (Latanoprost), held by Somerset, was first approved by FDA on Mar 22, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2011
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 22, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Latanoprost0.005% · solution/drops;ophthalmic	Latanoprost	Rx

All 4 submissions, including labeling and manufacturing supplements


Dec 5, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Feb 19, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 19, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Mar 22, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201786
Drugs@FDA: Overview at FDA
Company: Somerset Therapeutics

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