# ANDA Submissions – Prior Approval Supplements Under GDUFA:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/anda-submissions-prior-approval-supplements-under-gdufa-guidance-for-industry/433ffd43-857c-4bec-84e3-acc6a271a04c

> FDA guidance document: ANDA Submissions – Prior Approval Supplements Under GDUFA:  Guidance for Industry. Issue date: October 14, 2022. Get complete insights and analysis.

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## Details

- Title: ANDA Submissions – Prior Approval Supplements Under GDUFA:  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: 2022-10-14
- Last Changed: 2023-01-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0901">FDA-2014-D-0901</a>

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