Zioptan

For open-angle glaucoma or ocular hypertension. NDA 202514, held by Thea Pharma. Tafluprost.

As of Nov 15, 2026, NDA 202514 (Zioptan), held by Thea Pharma, was first approved by FDA on Feb 10, 2012, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 10, 2012
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tafluprost Ophthalmic Solution 0.0015% is indicated for reducing 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
Feb 10, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zioptan0.0015% · solution/drops;ophthalmic	Tafluprost	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Feb 25, 2026	Supplement 8Labeling · Standard review	Approved	Label Letter
Sep 4, 2015	Supplement 4Labeling · Standard review	Approved	Letter Label
Sep 4, 2015	Supplement 3Manufacturing · Standard review	Approved	Letter Label
Aug 28, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 22, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Feb 10, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 202514
Drugs@FDA: Overview at FDA
Company: Thea Pharma

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