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Name
Abbreviated New Drug Application (ANDA)
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Definition
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
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Alternate Names
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Abstractor Notes
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Histology
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Primary Sites
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