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FDA ANDA · ANDA218087

LOTEPREDNOL ETABONATE

Sponsor: LUPIN

APPLICATION
ANDA218087
TYPE
ANDA
ORIGINAL APPROVAL
2025-06-30
LATEST ACTION
2025-06-30
ROUTE
OPHTHALMIC
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

LOTEPREDNOL ETABONATEPrescription
LOTEPREDNOL ETABONATE 0.38% · GEL · OPHTHALMIC

Approval history

2025-06-30UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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