# Drugs@FDA application NDA205054

> The official Drugs@FDA dataset lists original submission 1 for NDA 205054 with status AP dated 2018-08-28, and names leuprolide acetate among the application record's active ingredients.

- Evidence object: `story:fda-drugs-nda205054:v1`
- Evidence domain: Regulatory
- Date in source: 2018-08-28
- Source checked: 2026-08-14
- Published by PeptideScanner: 2026-08-14
- Story landing page: https://peptidescanner.com/stories/fda-drugs-nda205054/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-drugs-nda205054-v1.json
- Content SHA-256: `d1e81543a7b4b005c681cc468b8f56cc5c762483fd4cf93f6e2ea9d6aa999d0d`

## Claims and source pins

### Headline

Drugs@FDA application NDA205054 ([`fda-drugs-nda205054-2018-08-28-d3de69f79957`](#source-fda-drugs-nda205054-2018-08-28-d3de69f79957))

### Summary

The official Drugs@FDA dataset lists original submission 1 for NDA 205054 with status AP dated 2018-08-28, and names leuprolide acetate among the application record's active ingredients. ([`fda-drugs-nda205054-2018-08-28-d3de69f79957`](#source-fda-drugs-nda205054-2018-08-28-d3de69f79957))

### Paragraph 1

The official Drugs@FDA dataset lists original submission 1 for NDA 205054 with status AP dated 2018-08-28, and names leuprolide acetate among the application record's active ingredients. ([`fda-drugs-nda205054-2018-08-28-d3de69f79957`](#source-fda-drugs-nda205054-2018-08-28-d3de69f79957))

### 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-nda205054-2018-08-28-d3de69f79957`](#source-fda-drugs-nda205054-2018-08-28-d3de69f79957))

## Sources

<a id="source-fda-drugs-nda205054-2018-08-28-d3de69f79957"></a>
- **Drugs@FDA application NDA205054 · original submission status AP · 2018-08-28 · dataset 2026-08-13** — Drugs@FDA via openFDA; class A. [Open source](https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22NDA205054%22&limit=1) (`fda-drugs-nda205054-2018-08-28-d3de69f79957`)

## 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 NDA205054." Version 1, published 2026-08-14. https://peptidescanner.com/evidence/v1/objects/fda-drugs-nda205054-v1.json SHA-256: d1e81543a7b4b005c681cc468b8f56cc5c762483fd4cf93f6e2ea9d6aa999d0d.