APPLICATION
ANDA216343
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-23
LATEST ACTION
2025-05-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION, GEL FORMING/DROPS
MARKETING STATUS
Discontinued
Products
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
Approval history
2025-05-19Labeling · Supplement 1 · 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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