Latanoprost

Reduces elevated intraocular pressure. ANDA 202442, held by Fdc Ltd. Latanoprost.

As of Nov 15, 2026, ANDA 202442 (Latanoprost), held by Fdc Ltd, was first approved by FDA on Apr 22, 2016, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2016
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Latanoprost Ophthalmic Solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure 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
Apr 22, 2016	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


Sep 22, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Nov 28, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Feb 19, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 19, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Feb 19, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Apr 22, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 202442
Drugs@FDA: Overview at FDA
Company: FDC Limited

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