NDA 20490, held by Allergan. Brimonidine Tartrate.
As of Nov 13, 2026, NDA 20490 (Alphagan), held by Allergan, was first approved by FDA on Mar 13, 1997, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2001 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 13, 1997 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alphagan0.5% · solution/drops;ophthalmic | Brimonidine Tartrate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Mar 23, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Dec 20, 2001 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Apr 9, 2001 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 26, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 20, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 15, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 13, 1997 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
