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CENTER FOR DRUG EVALUATION ANDRESEARCHAPPLICATION NUMBER:212273Orig1s000PRODUCT QUALITY REVIEW(S)QUALITY ASSESSMENTRecommendation: Approval 212273 Review #1 Drug Name/Dosage Form Strength Route of
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Appendix D glossary is a section in certain regulatory filings that provides definitions for terms and acronyms used within the document, ensuring clarity and consistency in interpretation.
Entities that are subject to regulatory requirements and need to clarify specific terminology within their filings are required to file the appendix D glossary.
To fill out the appendix D glossary, you should list each term alphabetically, provide a clear and concise definition, and ensure that it aligns with the context used in the main document.
The purpose of appendix D glossary is to provide clear definitions of terms used in regulatory documents to prevent misunderstandings and to ensure that all parties have a common understanding of key concepts.
The information reported in the appendix D glossary includes key terms, their definitions, and any acronyms that are pertinent to the regulatory filing.
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