# Changes to an Approved NDA or ANDA:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/changes-to-an-approved-nda-or-anda-guidance-for-industry/be4b40e4-e346-4d56-a97f-7b0099c36302

> FDA guidance document: Changes to an Approved NDA or ANDA:  Guidance for Industry. Issue date: April 08, 2004. Get complete insights and analysis.

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## Details

- Title: Changes to an Approved NDA or ANDA:  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: 2004-04-08
- Last Changed: 2020-05-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-0049">FDA-1999-D-0049</a>

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