APPLICATION
ANDA216361
TYPE
ANDA
ORIGINAL APPROVAL
2024-02-16
LATEST ACTION
2026-02-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
BRIMONIDINE TARTRATEOver-the-counter
BRIMONIDINE TARTRATE 0.025% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2026-02-11Labeling · Supplement 2 · 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.
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