APPLICATION
ANDA216328
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-15
LATEST ACTION
2024-10-15
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
OFLOXACINPrescription
OFLOXACIN 0.3% · SOLUTION/DROPS · OTIC
Approval history
2024-10-15UNKNOWN · Original · 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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