Issue Date: December 16, 2025
Issued by: Center for Drug Evaluation and Research
Topic(s): Drug Competition Action Plan, Generic Drugs
Status: Final
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry
This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (“earliest lawful ANDA approval date”).
Download the Guidance Document
