Drugs@FDA application timeline

NDA210797

2 dated FDA-coded AP submissions from 2019-10-08 through 2024-08-12, connected to 1 source-defined action assignments and 5 official document links.

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2Dated AP submissions

1Action assignments

5Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Afamelanotideafamelanotide

Newest first

Submission and document chronology

2 submissions

2024-08-12 · status AP

Supplement 7

FDA action labels
Labeling-Package Insert

2 official documents

Letter ↗2024-08-13 · FDA document 79384
Label ↗2024-08-13 · FDA document 79378

2019-10-08 · status AP

Original submission 1

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

3 official documents

Review ↗2020-07-15 · FDA document 63911
Label ↗2019-10-10 · FDA document 60510
Letter ↗2019-10-10 · FDA document 60508

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