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Guidance for Industry National Uniformity for Nonprescription Drugs Ingredient Listing for OTC Drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

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What is national uniformity for nonprescription?

National uniformity for nonprescription refers to the requirement for all nonprescription drug products to comply with the same standards and regulations across the country.

Who is required to file national uniformity for nonprescription?

Manufacturers and distributors of nonprescription drug products are required to file national uniformity for nonprescription.

How to fill out national uniformity for nonprescription?

National uniformity for nonprescription can be filled out online through the designated regulatory agency's website.

What is the purpose of national uniformity for nonprescription?

The purpose of national uniformity for nonprescription is to ensure the safety and effectiveness of nonprescription drug products available to consumers.

What information must be reported on national uniformity for nonprescription?

Information such as product labeling, active ingredients, dosage forms, and manufacturing practices must be reported on national uniformity for nonprescription.

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