Certain Postapproval Requirements and Resources for ANDAs

Issue Date: June 4, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Final

Certain Postapproval Requirements and Resources for ANDAs

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.

Download the Guidance Document

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