Referencing Approved Drug Products in ANDA Submissions Guidance for Industry October 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-0114.