# ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/anda-submissions-amendments-to-abbreviated-new-drug-applications-under-gdufa-guidance-for-industry/9fe16cd4-ef07-4dd1-8241-a762f71acbb7

> FDA guidance document: ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA:  Guidance for Industry. Issue date: September 11, 2024. Get complete insights and analysis.

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## Details

- Title: ANDA Submissions | Amendments to Abbreviated New Drug Applications 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: 2024-09-11
- Last Changed: 2024-09-16
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5670">FDA-2017-D-5670</a>

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