Alphagan P

Reduces elevated intraocular pressure (IOP). NDA 21262, held by Abbvie. Brimonidine Tartrate.

As of Nov 14, 2026, NDA 21262 (Alphagan P), held by Abbvie, was first approved by FDA on Mar 16, 2001, with 15 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2001
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) 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 16 submissions below


Dec 20, 2001	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Mar 16, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alphagan P0.15% · solution/drops;ophthalmic	Brimonidine Tartrate	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Sep 18, 2025	Supplement 28Labeling · Standard review	Approved	Letter Label
May 19, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 13, 2010	Supplement 20Labeling · Standard review	Approved	Label Letter
May 22, 2006	Supplement 18Labeling · Standard review	Approved	Letter Label
Feb 10, 2004	Supplement 10Manufacturing · Standard review	Approved	Letter
Feb 10, 2004	Supplement 13Labeling · Standard review	Approved	Letter
Jun 19, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 12, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 22, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 20, 2001	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 18, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 23, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 15, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 5, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21262
Drugs@FDA: Overview at FDA
Company: AbbVie

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