# Applications Covered by Section 505(b)(2) - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/applications-covered-by-section-505b2/5f0df47f-0a4f-498e-9b76-34682f4067f5

> FDA guidance document: Applications Covered by Section 505(b)(2). Issue date: December 08, 1999. Get complete insights and analysis.

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## Details

- Title: Applications Covered by Section 505(b)(2)
- 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: 1999-12-08
- Last Changed: 2021-02-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-0738">FDA-1999-D-0738</a>

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