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FDA ANDA · ANDA077847
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Sponsor: HIKMA
APPLICATION
ANDA077847
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-28
LATEST ACTION
2025-08-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDiscontinued
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2025-08-22Labeling · Supplement 15 · standardAP
2021-12-03Labeling · Supplement 12 · standardAP
2020-09-04Labeling · Supplement 5 · standardAP
2011-01-28Labeling · Supplement 2AP
2009-03-06Labeling · Supplement 1AP
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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