APPLICATION
ANDA076616
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-17
LATEST ACTION
2013-08-13
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OFLOXACINDiscontinued
OFLOXACIN 0.3% · SOLUTION/DROPS · OTIC
Approval history
2013-08-13Labeling · Supplement 3 · standardAP
2010-05-10Labeling · Supplement 1AP
2008-03-17OriginalAP
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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