Drugs@FDA application timeline

NDA208232

2 dated FDA-coded AP submissions from 2020-06-26 through 2024-07-11, connected to 2 source-defined action assignments and 5 official document links.

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2Dated AP submissions

2Action assignments

5Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Octreotideoctreotide acetate

Newest first

Submission and document chronology

2 submissions

2024-07-11 · status AP

Supplement 6

FDA action labels
Labeling-Package Insert · Labeling-Patient Package Insert

2 official documents

Label ↗2024-07-15 · FDA document 79091
Letter ↗2024-07-15 · FDA document 79068

2020-06-26 · status AP

Original submission 1

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

3 official documents

Review ↗2021-03-11 · FDA document 86527
Label ↗2020-07-09 · FDA document 63836
Letter ↗2020-06-30 · FDA document 63753

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