Drugs@FDA application timeline

NDA213793

6 dated FDA-coded AP submissions from 2020-11-25 through 2026-03-19, connected to 7 source-defined action assignments and 13 official document links.

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6Dated AP submissions

7Action assignments

13Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Setmelanotidesetmelanotide acetate

Newest first

Submission and document chronology

6 submissions

2026-03-19 · status AP

Supplement 9

FDA action labels
Efficacy-New Indication

2 official documents

Label ↗2026-03-24 · FDA document 85504
Letter ↗2026-03-23 · FDA document 85450

2025-08-21 · status AP

Supplement 8

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

2 official documents

Letter ↗2025-08-25 · FDA document 83184
Label ↗2025-08-25 · FDA document 83183

2024-12-20 · status AP

Supplement 7

FDA action labels
Efficacy-New Indication

2 official documents

Letter ↗2025-01-15 · FDA document 80711
Label ↗2024-12-23 · FDA document 80697

2023-11-15 · status AP

Supplement 5

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2023-11-16 · FDA document 76591
Letter ↗2023-11-16 · FDA document 76581

2022-06-16 · status AP

Supplement 1

FDA action labels
Efficacy-New Indication

2 official documents

Letter ↗2022-06-17 · FDA document 71347
Label ↗2022-06-16 · FDA document 71340

2020-11-25 · status AP

Original submission 1

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

3 official documents

Review ↗2020-12-23 · FDA document 65729
Label ↗2020-12-23 · FDA document 65422
Letter ↗2020-12-07 · FDA document 65358

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