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CENTER FOR DRUG EVALUATION ANDRESEARCHAPPLICATION NUMBER:212028Orig1s000PRODUCT QUALITY REVIEW(S)RECOMMENDATIONApproval Approval with Postmarking Commitment Complete Response 212028Assessment#01Lemborexant
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PDF Center for drug is a platform where pharmaceutical companies are required to electronically submit information regarding drug products to regulatory authorities.
Pharmaceutical companies and drug manufacturers are required to file PDF Center for drug.
Pharmaceutical companies can fill out PDF Center for drug by logging into the platform, entering the required information, and submitting the data electronically.
The purpose of PDF Center for drug is to ensure regulatory authorities have up-to-date and accurate information about drug products in the market.
Information such as drug product name, active ingredients, dosage form, strength, manufacturer information, labeling, and adverse reactions must be reported on PDF Center for drug.
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