APPLICATION
ANDA078981
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-13
LATEST ACTION
2023-01-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
DORZOLAMIDE HYDROCHLORIDEPrescription
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2023-01-23Labeling · Supplement 6 · standardAP
2020-03-25Labeling · Supplement 5 · standardAP
2009-04-13OriginalAP
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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