Drugs@FDA application timeline

NDA213182

1 dated FDA-coded AP submissions from 2020-01-16 through 2020-01-16, connected to 0 source-defined action assignments and 4 official document links.

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1Dated AP submissions

0Action assignments

4Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Semaglutidesemaglutide

Newest first

Submission and document chronology

1 submissions

2020-01-16 · status AP

Original submission 1

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

4 official documents

Review ↗2020-06-29 · FDA document 63744
Letter ↗2020-01-17 · FDA document 61602
Medication Guide ↗2020-01-17 · FDA document 61590
Label ↗2020-01-17 · FDA document 61589

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