FDA guidance
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for…
FDA guidance · Final · issued Dec 1, 2000
Key facts
| Title | Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Dec 1, 2000 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Docket number | None found |
| 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