Latanoprost

ANDA 77697, held by Apotex Inc. Latanoprost.

As of Nov 15, 2026, ANDA 77697 (Latanoprost), held by Apotex Inc, was first approved by FDA on Mar 22, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 17, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Nov 28, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Mar 22, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77697
Drugs@FDA: Overview at FDA
Company: Apotex

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