FDA NDA · NDA021262

ALPHAGAN P

brimonidine tartrate

Sponsor: ABBVIE

APPLICATION

NDA021262

TYPE

NDA

ORIGINAL APPROVAL

2001-03-16

LATEST ACTION

2025-09-18

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

ALPHAGAN P · ReferencePrescription

BRIMONIDINE TARTRATE 0.15% · SOLUTION/DROPS · OPHTHALMIC

2025-09-18Labeling · Supplement 28 · standard — Letter ↗AP

2014-05-19Manufacturing (CMC) · Supplement 24 · standardAP

2010-08-13Labeling · Supplement 20 · standard — Label ↗AP

2006-05-22Labeling · Supplement 18 · standard — Label ↗AP

2004-02-10Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP

2004-02-10Labeling · Supplement 13 · standard — Letter ↗AP

2002-06-19Manufacturing (CMC) · Supplement 8 · standardAP

2002-04-12Manufacturing (CMC) · Supplement 9 · standardAP

2002-01-22Manufacturing (CMC) · Supplement 7 · standardAP

2001-12-20Efficacy · Supplement 6 · standard — Review ↗AP

2001-12-18Manufacturing (CMC) · Supplement 4 · standardAP

2001-12-04Manufacturing (CMC) · Supplement 5 · standardAP

2001-10-23Manufacturing (CMC) · Supplement 1 · standardAP

2001-10-15Manufacturing (CMC) · Supplement 3 · standardAP

2001-06-05Manufacturing (CMC) · Supplement 2 · standardAP

2001-03-16Type 3 - New Dosage Form · Original · standard — Label ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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