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GUIDANCE DOCUMENT

Certain Postapproval Requirements and Resources for ANDAs June 2026

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist holders of abbreviated new drug applications (ANDAs) approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) by highlighting certain statutory and regulatory requirements for ANDAs postapproval, as well as identifying related guidances and other resources that ANDA holders should reference.

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Submit Comments Online

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-6821.

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