Drugs@FDA application timeline

NDA213150

6 dated FDA-coded AP submissions from 2020-05-01 through 2025-09-23, connected to 4 source-defined action assignments and 13 official document links.

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6Dated AP submissions

4Action assignments

13Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Leuprolideleuprolide acetate

Newest first

Submission and document chronology

6 submissions

2025-09-23 · status AP

Supplement 11

FDA action labels
Labeling-Package Insert

3 official documents

Medication Guide ↗2025-09-25 · FDA document 83471
Label ↗2025-09-25 · FDA document 83470
Letter ↗2025-09-24 · FDA document 83428

2025-05-05 · status AP

Supplement 7

FDA action labels
Labeling-Container/Carton Labels

1 official document

Letter ↗2025-05-08 · FDA document 82168

2024-10-17 · status AP

Supplement 4

FDA action labels
Labeling-Container/Carton Labels

2 official documents

Label ↗2024-10-21 · FDA document 79945
Letter ↗2024-10-18 · FDA document 79914

2022-11-25 · status AP

Supplement 3

No source action-type assignment was retained for this submission.

2 official documents

Letter ↗2022-11-28 · FDA document 72730
Label ↗2022-11-28 · FDA document 72729

2022-04-22 · status AP

Supplement 2

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2022-04-27 · FDA document 70822
Letter ↗2022-04-26 · FDA document 70812

2020-05-01 · status AP

Original submission 1

No source action-type assignment was retained for this submission.

3 official documents

Review ↗2021-01-21 · FDA document 65951
Letter ↗2020-05-05 · FDA document 62822
Label ↗2020-05-04 · FDA document 62815

Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.