Issue Date: October 27, 2020
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Final
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
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.
Download the Guidance Document
