APPLICATION
ANDA075446
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-28
LATEST ACTION
2015-09-10
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
BETAXOLOL HYDROCHLORIDEDiscontinued
BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2015-09-10Labeling · Supplement 16 · standardAP
2001-10-03Manufacturing (CMC) · Supplement 1AP
2001-08-30Manufacturing (CMC) · Supplement 3AP
2001-07-30Manufacturing (CMC) · Supplement 2AP
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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