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This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission.
In general, to obtain approval of an ANDA for a generic drug, an ANDA applicant first must identify the previously approved drug product it seeks to duplicate, i.e., the reference listed drug (RLD), and must show, among other things, that the generic drug is bioequivalent to the RLD.