Latanoprost

ANDA 202077, held by Carnegie. Latanoprost.

As of Nov 15, 2026, ANDA 202077 (Latanoprost), held by Carnegie, was first approved by FDA on Feb 11, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 11, 2013
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
Feb 11, 2013	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 1Labeling · Standard review	Approved	None posted
Feb 11, 2013	Original application	Approved	None posted
Feb 11, 2013	Supplement 11	Approved	None posted

Identifiers

Application: ANDA 202077
Drugs@FDA: Overview at FDA
Company: Carnegie

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