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This document provides a detailed chemistry review of the NDA for Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution, including assessments of drug substance and product, specifications,
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What is Chemistry Review NDA 22-428?
Chemistry Review NDA 22-428 is a submission form used in the regulatory process for approving new drugs, specifically focusing on the chemistry, manufacturing, and controls of the drug product.
Who is required to file Chemistry Review NDA 22-428?
Pharmaceutical companies or sponsors who are seeking approval for a new drug application (NDA) must file Chemistry Review NDA 22-428 as part of their submission.
How to fill out Chemistry Review NDA 22-428?
To fill out Chemistry Review NDA 22-428, applicants need to provide detailed information regarding the drug's chemical structure, manufacturing processes, quality control measures, and analytical methods used for testing.
What is the purpose of Chemistry Review NDA 22-428?
The purpose of Chemistry Review NDA 22-428 is to ensure that the chemical properties and manufacturing processes of a new drug are adequately understood and controlled to ensure safety, efficacy, and quality.
What information must be reported on Chemistry Review NDA 22-428?
The information that must be reported includes drug composition, manufacturing processes, stability data, and specifications for quality control tests, as well as any relevant analytical methods.
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