# Drugs@FDA application ANDA212963

> The official Drugs@FDA dataset lists original submission 1 for ANDA 212963 with status AP dated 2022-06-06, and names leuprolide acetate among the application record's active ingredients.

- Evidence object: `story:fda-drugs-anda212963:v1`
- Evidence domain: Regulatory
- Date in source: 2022-06-06
- Source checked: 2026-08-14
- Published by PeptideScanner: 2026-08-14
- Story landing page: https://peptidescanner.com/stories/fda-drugs-anda212963/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda212963-v1.json
- Content SHA-256: `7c33a18c1dd0025ffa0ffa933cdc5d9353b5f769b8649c22f6a786e95aa714d0`

## Claims and source pins

### Headline

Drugs@FDA application ANDA212963 ([`fda-drugs-anda212963-2022-06-06-76078963da00`](#source-fda-drugs-anda212963-2022-06-06-76078963da00))

### Summary

The official Drugs@FDA dataset lists original submission 1 for ANDA 212963 with status AP dated 2022-06-06, and names leuprolide acetate among the application record's active ingredients. ([`fda-drugs-anda212963-2022-06-06-76078963da00`](#source-fda-drugs-anda212963-2022-06-06-76078963da00))

### Paragraph 1

The official Drugs@FDA dataset lists original submission 1 for ANDA 212963 with status AP dated 2022-06-06, and names leuprolide acetate among the application record's active ingredients. ([`fda-drugs-anda212963-2022-06-06-76078963da00`](#source-fda-drugs-anda212963-2022-06-06-76078963da00))

### 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-anda212963-2022-06-06-76078963da00`](#source-fda-drugs-anda212963-2022-06-06-76078963da00))

## Sources

<a id="source-fda-drugs-anda212963-2022-06-06-76078963da00"></a>
- **Drugs@FDA application ANDA212963 · original submission status AP · 2022-06-06 · dataset 2026-08-13** — Drugs@FDA via openFDA; class A. [Open source](https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22ANDA212963%22&limit=1) (`fda-drugs-anda212963-2022-06-06-76078963da00`)

## 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 ANDA212963." Version 1, published 2026-08-14. https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda212963-v1.json SHA-256: 7c33a18c1dd0025ffa0ffa933cdc5d9353b5f769b8649c22f6a786e95aa714d0.