APPLICATION
ANDA091691
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-18
LATEST ACTION
2026-06-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
BRIMONIDINE TARTRATEPrescription
BRIMONIDINE TARTRATE 0.2% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2026-06-22Manufacturing (CMC) · Supplement 7 · unknownAP
2014-11-18Not Applicable · OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.