APPLICATION
ANDA078559
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-25
LATEST ACTION
2020-07-02
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
OFLOXACINPrescription
OFLOXACIN 0.3% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2020-07-02Labeling · Supplement 12 · standardAP
2015-03-12Manufacturing (CMC) · Supplement 8 · unknownAP
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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