FDA NDA · NDA021764

BRIMONIDINE TARTRATE

Sponsor: SANDOZ

APPLICATION

NDA021764

TYPE

NDA

ORIGINAL APPROVAL

2006-05-22

LATEST ACTION

2025-11-21

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

QOLIANA · ReferencePrescription

BRIMONIDINE TARTRATE 0.15% · SOLUTION/DROPS · OPHTHALMIC

2025-11-21Labeling · Supplement 12 · standard — Letter ↗AP

2016-01-19Manufacturing (CMC) · Supplement 10 · standardAP

2015-11-10Manufacturing (CMC) · Supplement 9 · standardAP

2014-09-25Manufacturing (CMC) · Supplement 6 · standardAP

2012-03-27Labeling · Supplement 5 · unknown — Label ↗AP

2010-08-03Labeling · Supplement 2 · standard — Label ↗AP

2006-05-22Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.