Latanoprost

ANDA 200925, held by J Molner. Latanoprost.

As of Nov 15, 2026, ANDA 200925 (Latanoprost), held by J Molner, 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

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


Aug 23, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jun 12, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jun 12, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Mar 22, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200925
Drugs@FDA: Overview at FDA
Company: J. Molner

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