# Determining Whether to Submit an ANDA or a 505(b)(2) Application - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/determining-whether-to-submit-an-anda-or-a-505b2-application/c04d36f1-c78a-4aaf-8e45-6a99420cf632

> FDA guidance document: Determining Whether to Submit an ANDA or a 505(b)(2) Application. Issue date: May 10, 2019. Get complete insights and analysis.

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## Details

- Title: Determining Whether to Submit an ANDA or a 505(b)(2) Application
- 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: 2019-05-10
- Last Changed: 2020-04-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5974">FDA-2017-D-5974</a>

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