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3. Agency Component Abbreviations Component AbbreviationComponent Name IV. EXEMPTION 3 STATUTESType of Information WithheldStatuteN/AN/Case Citation/Agency / ComponentMMCTotal Number of Times Relied
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To fill out abbreviations worldwide, follow these steps:
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Start by identifying the abbreviation you need to fill out.
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Research the full meaning of the abbreviation using reliable sources such as dictionaries, official documents, or specialized websites.
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Write down the full expanded form of the abbreviation.
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Abbreviations stands for Abbreviated New Drug Application which is submitted to FDA for the approval of a generic drug.
Abbreviations are typically filed by pharmaceutical companies seeking approval to market a generic version of a brand-name drug.
Abbreviations need to be filled out following the guidelines provided by the FDA, including submitting information on the generic drug's formulation, bioequivalence, and labeling.
The purpose of abbreviations is to allow for the approval and marketing of generic versions of brand-name drugs, increasing competition and potentially lowering drug prices.
Information such as the generic drug's formulation, bioequivalence data, labeling information, and any differences between the generic and brand-name drug must be reported.
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