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CENTER FOR DRUG EVALUATION ANDRESEARCHAPPLICATION NUMBER:210730Orig1s000PRODUCT QUALITY REVIEW(S)Table of ContentsExecutive Summary...3Drug Substance.7Drug Product.15Environmental..... N/Labeling.....28Process/Manufacturing.

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211616orig1s000 is a form related to food and beverage reporting, used to track and manage food safety and regulatory compliance.

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The form requires information such as business details, food safety standards adherence, inventory details, and regulatory compliance documentation.

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