FDA guidance
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits…
FDA guidance · Final · issued Sep 14, 2016
Key facts
| Title | ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Sep 14, 2016 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Topics | User Fees |
| Docket number | FDA-2014-D-1292 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents