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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022581Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review 26 February 2010 NDA: 22-581/N000 Drug Product Name Proprietary:
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Printed labeling refers to any written, printed, or graphic matter accompanying a product and includes the labels, information leaflets, package inserts, and any other materials provided with or on the product.
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The manufacturer or distributor of the product is typically responsible for filing the printed labeling with the appropriate regulatory authorities.
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The specific requirements for filling out printed labeling may vary depending on the product and the regulatory authority. It is important to consult the relevant regulations and guidelines to ensure compliance.
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The purpose of printed labeling is to provide important information about the product, including its ingredients, directions for use, warnings, and precautions. It helps ensure that consumers have the necessary information to safely and effectively use the product.
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The specific information that must be reported on printed labeling can vary depending on the product and the regulatory authority. However, common requirements may include the product's name, active ingredients, dosage instructions, and any applicable warnings or precautions.
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