# ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs:  Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/anda-submissions-amendments-and-requests-for-final-approval-to-tentatively-approved-andas-guidance-for-industry/cd346cb2-e226-4779-be3a-218d45e8d794

> FDA guidance document: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs:  Guidance for Industry. Issue date: December 16, 2025. Get complete insights and analysis.

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## Details

- Title: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-12-16
- Last Changed: 2025-12-16
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-4726">FDA-2018-D-4726</a>

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