APPLICATION
ANDA078480
TYPE
ANDA
ORIGINAL APPROVAL
2022-12-21
LATEST ACTION
2026-05-20
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
BRIMONIDINE TARTRATEPrescription
BRIMONIDINE TARTRATE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2026-05-20Labeling · Supplement 5 · standardAP
2022-12-21OriginalAP
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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