# Drugs@FDA application NDA019010

> The official Drugs@FDA dataset lists original submission 1 for NDA 019010 with status AP dated 1985-04-09, and names leuprolide acetate among the application record's active ingredients.

- Evidence object: `story:fda-drugs-nda019010:v1`
- Evidence domain: Regulatory
- Date in source: 1985-04-09
- Source checked: 2026-08-14
- Published by PeptideScanner: 2026-08-14
- Story landing page: https://peptidescanner.com/stories/fda-drugs-nda019010/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-drugs-nda019010-v1.json
- Content SHA-256: `295d716478777fd5f7546a20a07a594030023153b9a77734a246fae77d43e65f`

## Claims and source pins

### Headline

Drugs@FDA application NDA019010 ([`fda-drugs-nda019010-1985-04-09-d97355079c93`](#source-fda-drugs-nda019010-1985-04-09-d97355079c93))

### Summary

The official Drugs@FDA dataset lists original submission 1 for NDA 019010 with status AP dated 1985-04-09, and names leuprolide acetate among the application record's active ingredients. ([`fda-drugs-nda019010-1985-04-09-d97355079c93`](#source-fda-drugs-nda019010-1985-04-09-d97355079c93))

### Paragraph 1

The official Drugs@FDA dataset lists original submission 1 for NDA 019010 with status AP dated 1985-04-09, and names leuprolide acetate among the application record's active ingredients. ([`fda-drugs-nda019010-1985-04-09-d97355079c93`](#source-fda-drugs-nda019010-1985-04-09-d97355079c93))

### 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-nda019010-1985-04-09-d97355079c93`](#source-fda-drugs-nda019010-1985-04-09-d97355079c93))

## Sources

<a id="source-fda-drugs-nda019010-1985-04-09-d97355079c93"></a>
- **Drugs@FDA application NDA019010 · original submission status AP · 1985-04-09 · dataset 2026-08-13** — Drugs@FDA via openFDA; class A. [Open source](https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22NDA019010%22&limit=1) (`fda-drugs-nda019010-1985-04-09-d97355079c93`)

## 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 NDA019010." Version 1, published 2026-08-14. https://peptidescanner.com/evidence/v1/objects/fda-drugs-nda019010-v1.json SHA-256: 295d716478777fd5f7546a20a07a594030023153b9a77734a246fae77d43e65f.