APPLICATION
ANDA218819
TYPE
ANDA
ORIGINAL APPROVAL
2026-02-12
LATEST ACTION
2026-02-12
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
FLUOROMETHOLONEPrescription
FLUOROMETHOLONE 0.1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2026-02-12UNKNOWN · 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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