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FDA NDA · NDA200738

LOTEMAX

loteprednol etabonate

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA200738
TYPE
NDA
ORIGINAL APPROVAL
2011-04-15
LATEST ACTION
2020-12-08
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

LOTEMAX · ReferencePrescription
LOTEPREDNOL ETABONATE 0.5% · OINTMENT · OPHTHALMIC

Approval history

2020-12-08Labeling · Supplement 3 · standard — Letter ↗AP
2011-04-15Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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