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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Not for implementation.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.

Referencing Approved Drug Products in ANDA Submissions Guidance for Industry

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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.