# Drugs@FDA application ANDA076313

> The official Drugs@FDA dataset lists original submission 1 for ANDA 076313 with status AP dated 2005-03-28, and names octreotide acetate among the application record's active ingredients.

- Evidence object: `story:fda-drugs-anda076313:v1`
- Evidence domain: Regulatory
- Date in source: 2005-03-28
- Source checked: 2026-08-14
- Published by PeptideScanner: 2026-08-14
- Story landing page: https://peptidescanner.com/stories/fda-drugs-anda076313/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda076313-v1.json
- Content SHA-256: `28d7f19e8fecd6bb404c6f5bc6d53c853940a47bc407b8a2ba5954f792672f8b`

## Claims and source pins

### Headline

Drugs@FDA application ANDA076313 ([`fda-drugs-anda076313-2005-03-28-256c127ffbf0`](#source-fda-drugs-anda076313-2005-03-28-256c127ffbf0))

### Summary

The official Drugs@FDA dataset lists original submission 1 for ANDA 076313 with status AP dated 2005-03-28, and names octreotide acetate among the application record's active ingredients. ([`fda-drugs-anda076313-2005-03-28-256c127ffbf0`](#source-fda-drugs-anda076313-2005-03-28-256c127ffbf0))

### Paragraph 1

The official Drugs@FDA dataset lists original submission 1 for ANDA 076313 with status AP dated 2005-03-28, and names octreotide acetate among the application record's active ingredients. ([`fda-drugs-anda076313-2005-03-28-256c127ffbf0`](#source-fda-drugs-anda076313-2005-03-28-256c127ffbf0))

### 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-anda076313-2005-03-28-256c127ffbf0`](#source-fda-drugs-anda076313-2005-03-28-256c127ffbf0))

## Sources

<a id="source-fda-drugs-anda076313-2005-03-28-256c127ffbf0"></a>
- **Drugs@FDA application ANDA076313 · original submission status AP · 2005-03-28 · dataset 2026-08-13** — Drugs@FDA via openFDA; class A. [Open source](https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22ANDA076313%22&limit=1) (`fda-drugs-anda076313-2005-03-28-256c127ffbf0`)

## 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 ANDA076313." Version 1, published 2026-08-14. https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda076313-v1.json SHA-256: 28d7f19e8fecd6bb404c6f5bc6d53c853940a47bc407b8a2ba5954f792672f8b.