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

Source: https://www.globalkeysolutions.net/guidances/guidance-document/changes-to-an-approved-nda-or-anda-questions-and-answers-guidance-for-industry/35e76fcd-a993-489c-8472-73c4bbb60d94

> FDA guidance document: Changes to an Approved NDA or ANDA: Questions and Answers:  Guidance for Industry. Issue date: January 01, 2001. Get complete insights and analysis.

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## Details

- Title: Changes to an Approved NDA or ANDA: Questions and Answers:  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: 2001-01-01
- Last Changed: 2021-01-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-0049">FDA-1999-D-0049</a>

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