ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

On 28 September 2020 the FDA announced the availability of the final 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").

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