# ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/andas-pre-submission-of-facility-information-related-to-prioritized-generic-drug-applications-pre-submission-facility-correspondence-guidance-for-industry/b98ece19-e078-446b-9b61-835924e31cd9

> FDA guidance document: ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry. Issue date: November 03, 2017. Get complete insights and analysis.

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## Details

- Title: ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) 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: 2017-11-03
- Comment Close Date: 2018-02-02
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-3101">FDA-2017-D-3101</a>

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