# ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/anda-submissions-refuse-to-receive-for-lack-of-justification-of-impurity-limits-guidance-for-industry/29897d63-6e30-44a4-ac28-8fbd517e9e00

> FDA guidance document: ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits:  Guidance for Industry. Issue date: September 14, 2016. Get complete insights and analysis.

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## Details

- Title: ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits:  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: 2016-09-14
- Last Changed: 2020-04-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-1292">FDA-2014-D-1292</a>

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