APPLICATION
ANDA217597
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-10
LATEST ACTION
2025-12-10
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
LOTEPREDNOL ETABONATE AND TOBRAMYCINPrescription
LOTEPREDNOL ETABONATE 0.5%, TOBRAMYCIN 0.3% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.