APPLICATION
ANDA078771
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-28
LATEST ACTION
2025-05-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION/DROPS · OPHTHALMIC
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2025-05-16Manufacturing (CMC) · Supplement 9 · unknownAP
2009-09-28OriginalAP
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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