Issue Date: August 18, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Drugs, Generic Drugs, Drug Competition Action Plan
Status: Draft
Determining Whether To Submit an ANDA or a 505(b)(2) Application
This draft guidance describes FDA’s current thinking on determining whether to submit an Abbreviated New Drug Application (ANDA) under section 505(j) of the FD&C Act or a 505(b)(2) application, including criteria for choosing between the two pathways and how to seek FDA’s assistance. This revised draft updates and supersedes the May 2019 version of this guidance with additional information on duplicates and eligibility requirements, along with clarified recommendations for industry.
Download the Guidance Document
