APPLICATION
ANDA077764
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-12
LATEST ACTION
2022-09-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
APRACLONIDINE HYDROCHLORIDEPrescription
APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2022-09-28Labeling · Supplement 2 · standardAP
2022-09-28Labeling · Supplement 1 · 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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