# Drugs@FDA application ANDA209564

> The official Drugs@FDA dataset lists original submission 1 for ANDA 209564 with status AP dated 2021-02-09, and names linaclotide among the application record's active ingredients.

- Evidence object: `story:fda-drugs-anda209564:v1`
- Evidence domain: Regulatory
- Date in source: 2021-02-09
- Source checked: 2026-08-14
- Published by PeptideScanner: 2026-08-14
- Story landing page: https://peptidescanner.com/stories/fda-drugs-anda209564/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda209564-v1.json
- Content SHA-256: `40cc4ba077758baec3ef8717fbc9a8d534532ccbf8a8e08af02a9ffea87bce1a`

## Claims and source pins

### Headline

Drugs@FDA application ANDA209564 ([`fda-drugs-anda209564-2021-02-09-c16b14d7f4e0`](#source-fda-drugs-anda209564-2021-02-09-c16b14d7f4e0))

### Summary

The official Drugs@FDA dataset lists original submission 1 for ANDA 209564 with status AP dated 2021-02-09, and names linaclotide among the application record's active ingredients. ([`fda-drugs-anda209564-2021-02-09-c16b14d7f4e0`](#source-fda-drugs-anda209564-2021-02-09-c16b14d7f4e0))

### Paragraph 1

The official Drugs@FDA dataset lists original submission 1 for ANDA 209564 with status AP dated 2021-02-09, and names linaclotide among the application record's active ingredients. ([`fda-drugs-anda209564-2021-02-09-c16b14d7f4e0`](#source-fda-drugs-anda209564-2021-02-09-c16b14d7f4e0))

### Paragraph 2

This page reports bounded application metadata attributed to Drugs@FDA. It does not reproduce labeling, describe an indication, compare products, or provide medical guidance. ([`fda-drugs-anda209564-2021-02-09-c16b14d7f4e0`](#source-fda-drugs-anda209564-2021-02-09-c16b14d7f4e0))

## Sources

<a id="source-fda-drugs-anda209564-2021-02-09-c16b14d7f4e0"></a>
- **Drugs@FDA application ANDA209564 · original submission status AP · 2021-02-09 · dataset 2026-08-13** — Drugs@FDA via openFDA; class A. [Open source](https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22ANDA209564%22&limit=1) (`fda-drugs-anda209564-2021-02-09-c16b14d7f4e0`)

## Correction lineage

No correction is recorded for this version.

## Reporting boundaries and unknowns

PeptideScanner reports the cited regulator or label record. It does not extend that record into broader safety, effectiveness, or approval claims.

- Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.
- This object does not determine whether cited records agree, corroborate one another, or establish scientific truth.
- This object does not determine safety, efficacy, causality, or suitability for any person.

Methodology: https://peptidescanner.com/methodology/
Medical disclaimer: https://peptidescanner.com/medical-disclaimer/

## Suggested citation

PeptideScanner. "Drugs@FDA application ANDA209564." Version 1, published 2026-08-14. https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda209564-v1.json SHA-256: 40cc4ba077758baec3ef8717fbc9a8d534532ccbf8a8e08af02a9ffea87bce1a.