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GUIDANCE DOCUMENT

Referencing Approved Drug Products in ANDA Submissions Guidance for Industry January 2017

Draft

Not for implementation. Contains non-binding recommendations.

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.


Submit Comments

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:

Dockets Management
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.

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