APPLICATION
ANDA078395
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-28
LATEST ACTION
2021-12-03
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
DORZOLAMIDE HYDROCHLORIDEPrescription
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2021-12-03Labeling · Supplement 10 · standardAP
2015-11-27Labeling · Supplement 8 · standardAP
2011-01-28Labeling · Supplement 4AP
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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