← FDA DRUG APPROVALS
FDA ANDA · ANDA219166
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
brimonidine tartrate and timolol maleate
Sponsor: GLAND
APPLICATION
ANDA219166
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-11
LATEST ACTION
2026-06-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
BRIMONIDINE TARTRATE AND TIMOLOL MALEATEPrescription
BRIMONIDINE TARTRATE 0.2%, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2026-06-11UNKNOWN · Original · standardAP
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.