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# Revised FDA Procedure on ANDA Suitability Petitions
- URL: https://www.fdaweb.com/revised-fda-procedure-on-anda-suitability-petitions/
- Published: 2020-10-09T12:00:00.000Z
- Updated: 2026-09-14T16:32:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147844

FDA has issued a revised Manual of Policies and Procedures (MAPP) on [ANDA Suitability Petitions](https://www.fda.gov/media/86656/download?ref=fdaweb.com) to clarify certain issues and include minor updates to the process and organization. The MAPP establishes the policies and procedures for CDER’s Office of Generic Drugs to respond to suitability petitions submitted to it by or on behalf of prospective ANDA applicants. A prospective applicant may submit a petition requesting permission to submit an ANDA for a generic drug product that differs from a reference listed drug in its route of administration, dosage form, or strength, or that has one different active ingredient in a fixed-combination drug product (i.e., a drug product with multiple active ingredients).