Docket Number:
FDA-2017-D-0114
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission.

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All written comments should be identified with this document's docket number: FDA-2017-D-0114.