APPLICATION
ANDA215886
TYPE
ANDA
ORIGINAL APPROVAL
2022-11-23
LATEST ACTION
2023-08-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
OFLOXACINPrescription
OFLOXACIN 0.3% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2023-08-25Manufacturing (CMC) · Supplement 2 · unknownAP
2022-11-23UNKNOWN · 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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