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FDA ANDA · ANDA202054
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE
ddorzolamide hydrochloride timolol maleate
Sponsor: REGCON HOLDINGS
APPLICATION
ANDA202054
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-03
LATEST ACTION
2024-02-20
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
2024-02-20Labeling · Supplement 7 · standardAP
2021-02-10Labeling · 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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