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FDA Bioequivalence Review Memo for ANDA 215719 – Loteprednol Etabonate Ophthalmic Suspension
FDA Bioequivalence Review Memo for ANDA 215719 – Loteprednol Etabonate Ophthalmic Suspension
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Original Request: We request FDA’s bioequivalence review memo(s) and associated correspondence for ANDA 215719 for loteprednol etabonate ophthalmic suspension/drops, 0.5%.
Tags: Pharma, ANDA, 2025
Tags: Pharma, ANDA, 2025
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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