# Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/changes-to-an-approved-nda-or-anda-specifications-use-of-enforcement-discretion-for-compendial-changes-guidance-for-industry/1aafb7d9-76d0-4fff-8835-a361bbb77c9b

> FDA guidance document: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes:  Guidance for Industry. Issue date: November 22, 2004. Get complete insights and analysis.

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## Details

- Title: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes:  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: 2004-11-22
- Last Changed: 2020-05-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2004-D-0179">FDA-2004-D-0179</a>

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