Latanoprost

Reduces elevated intraocular pressure (IOP). ANDA 201006, held by Bausch And Lomb. Latanoprost.

As of Nov 15, 2026, ANDA 201006 (Latanoprost), held by Bausch And Lomb, was first approved by FDA on Mar 22, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2011
Supplements approved: 5
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 6 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 6 submissions, including labeling and manufacturing supplements


Dec 27, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Sep 3, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Feb 21, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Dec 9, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Feb 27, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Mar 22, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201006
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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