Drugs@FDA application timeline

NDA215866

11 dated FDA-coded AP submissions from 2022-05-13 through 2026-01-20, connected to 16 source-defined action assignments and 27 official document links.

Open selected original record Open Drugs@FDA source ↗Download full history JSON

11Dated AP submissions

16Action assignments

27Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Tirzepatidetirzepatide

Newest first

Submission and document chronology

11 submissions

2026-01-20 · status AP

Supplement 9

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

4 official documents

Medication Guide ↗2026-01-21 · FDA document 84798
Label ↗2026-01-21 · FDA document 84797
Letter ↗2026-01-21 · FDA document 84788
Letter ↗2026-01-21 · FDA document 84787

2026-01-07 · status AP

Supplement 41

FDA action labels
Manufacturing (CMC)-Packaging

3 official documents

Medication Guide ↗2026-01-08 · FDA document 84722
Label ↗2026-01-08 · FDA document 84721
Letter ↗2026-01-08 · FDA document 84716

2025-12-19 · status AP

Supplement 39

FDA action labels
Efficacy-New Patient Population

2 official documents

Letter ↗2025-12-23 · FDA document 84514
Label ↗2025-12-23 · FDA document 84507

2025-09-25 · status AP

Supplement 34

FDA action labels
Labeling-Medication Guide · Labeling-Package Insert

2 official documents

Label ↗2025-09-26 · FDA document 83557
Letter ↗2025-09-26 · FDA document 83541

2025-05-28 · status AP

Supplement 31

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2025-06-02 · FDA document 82379
Letter ↗2025-05-29 · FDA document 82350

2024-11-01 · status AP

Supplement 22

FDA action labels
Labeling-Medication Guide · Labeling-Package Insert

2 official documents

Label ↗2024-11-05 · FDA document 80136
Letter ↗2024-11-05 · FDA document 80132

2024-11-01 · status AP

Supplement 15

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2024-11-05 · FDA document 80137
Letter ↗2024-11-05 · FDA document 80131

2024-11-01 · status AP

Supplement 10

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2024-11-05 · FDA document 80138
Letter ↗2024-11-05 · FDA document 80130

2023-07-28 · status AP

Supplement 6

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2023-07-31 · FDA document 74960
Letter ↗2023-07-31 · FDA document 74957

2023-07-28 · status AP

Supplement 2

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

3 official documents

Review ↗2024-12-04 · FDA document 80489
Label ↗2023-07-31 · FDA document 74959
Letter ↗2023-07-31 · FDA document 74956

2022-05-13 · status AP

Original submission 1

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

3 official documents

Review ↗2022-06-15 · FDA document 71307
Letter ↗2022-05-16 · FDA document 71073
Label ↗2022-05-13 · FDA document 71068

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