Drugs@FDA application timeline

NDA205054

5 dated FDA-coded AP submissions from 2018-08-28 through 2024-11-14, connected to 5 source-defined action assignments and 11 official document links.

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5Dated AP submissions

5Action assignments

11Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Leuprolideleuprolide acetate

Newest first

Submission and document chronology

5 submissions

2024-11-14 · status AP

Supplement 7

FDA action labels
Labeling-Package Insert

2 official documents

Letter ↗2024-11-15 · FDA document 80221
Label ↗2024-11-15 · FDA document 80220

2024-08-08 · status AP

Supplement 6

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2024-08-12 · FDA document 79363
Letter ↗2024-08-09 · FDA document 79357

2023-11-30 · status AP

Supplement 5

FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert

2 official documents

Letter ↗2023-12-01 · FDA document 76713
Label ↗2023-12-01 · FDA document 76709

2023-02-28 · status AP

Supplement 4

FDA action labels
Efficacy-New Indication

2 official documents

Label ↗2023-03-01 · FDA document 73650
Letter ↗2023-03-01 · FDA document 73642

2018-08-28 · status AP

Original submission 1

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

3 official documents

Review ↗2019-04-04 · FDA document 58219
Label ↗2018-10-22 · FDA document 56051
Letter ↗2018-09-18 · FDA document 55508

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