Drugs@FDA application timeline

NDA210557

2 dated FDA-coded AP submissions from 2019-06-21 through 2020-10-23, 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

Bremelanotidebremelanotide acetate

Newest first

Submission and document chronology

2 submissions

2020-10-23 · status AP

Supplement 2

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2020-10-27 · FDA document 65041
Letter ↗2020-10-27 · FDA document 65030

2019-06-21 · status AP

Original submission 1

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

3 official documents

Review ↗2019-08-06 · FDA document 59579
Letter ↗2019-08-02 · FDA document 59164
Label ↗2019-06-21 · FDA document 59159

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