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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:214487Orig1s000 OTHER REVIEW(S)MEMORANDUM REVIEW OF REVISED LABEL AND LABELING Division of Medication Error Prevention and Analysis 1 (MEPA

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214487orig1s000 - accessdatafdagov is needed by individuals or organizations who are required to provide specific information to the FDA (Food and Drug Administration) as part of a regulatory process or compliance requirement. This may include manufacturers, distributors, importers, or other entities involved in the production, distribution, or importation of products regulated by the FDA.

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214487orig1s000 is a form used by the FDA for regulatory submissions related to specific drug or device information.

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Manufacturers and sponsors of drugs or medical devices required to report regulatory data to the FDA are obligated to file this form.

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The purpose of the form is to ensure compliance with FDA regulations and to facilitate the review of drug or device submissions.

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The form must include details such as the product's name, applicant information, and specific regulatory data pertinent to the submission.

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