
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.
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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.
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Information that must be reported includes product composition, manufacturing specifications, bioequivalence data, labeling information, and any clinical study results.
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