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FDA ANDA · ANDA205295
DORZOLAMIDE AND TIMOLOL
dorzolamide hydrochloride and timolol maleate ophthalmic solution
Sponsor: FDC LTD
APPLICATION
ANDA205295
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-13
LATEST ACTION
2025-05-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEPrescription
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2025-05-27Labeling · Supplement 12 · standardAP
2024-02-20Labeling · Supplement 8 · standardAP
2019-06-13UNKNOWN · 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.
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