Reduces elevated intraocular pressure (IOP). NDA 21770, held by Abbvie. Brimonidine Tartrate.
As of Nov 15, 2026, NDA 21770 (Alphagan P), held by Abbvie, was first approved by FDA on Aug 19, 2005, with 7 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alphagan P0.1% · solution/drops;ophthalmic | Brimonidine Tartrate | RxReference drug |
| Sep 18, 2025 | Supplement 14Labeling · Standard review | Approved | |
| May 5, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jan 22, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 13, 2010 | Supplement 4Labeling · Standard review | Approved | |
| Apr 17, 2006 | Supplement 1Manufacturing | Approved | |
| Aug 19, 2005 | Original applicationNew dosage form · Standard review | Approved |
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
