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Get the free About - Generic Product IdentifierMedi-SpanWolters Kluwer

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A generic product is a non-branded version of a medication that is equivalent to a branded product in dosage, strength, and intended use, often marketed at lower prices once patents expire.
Manufacturers and distributors of generic products are typically required to file information with regulatory bodies to ensure compliance with safety and efficacy standards.
Filling out the required information about a generic product involves providing detailed data on the product's formulation, manufacturing process, labeling, and expected use, as mandated by regulatory authorities.
The purpose of filing information about a generic product is to demonstrate that it meets regulatory standards for safety, efficacy, and quality, ensuring it is a suitable alternative to branded products.
Information that must be reported includes product composition, manufacturing specifications, bioequivalence data, labeling information, and any clinical study results.
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