Drugs@FDA application timeline

NDA217806

13 dated FDA-coded AP submissions from 2023-11-08 through 2026-02-25, connected to 21 source-defined action assignments and 33 official document links.

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13Dated AP submissions

21Action assignments

33Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Tirzepatidetirzepatide

Newest first

Submission and document chronology

13 submissions

2026-02-25 · status AP

Supplement 42

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2026-03-02 · FDA document 85191
Letter ↗2026-02-27 · FDA document 85180

2026-01-20 · status AP

Supplement 2

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

4 official documents

Medication Guide ↗2026-01-21 · FDA document 84796
Label ↗2026-01-21 · FDA document 84795
Letter ↗2026-01-21 · FDA document 84791
Letter ↗2026-01-21 · FDA document 84790

2026-01-07 · status AP

Supplement 37

FDA action labels
Manufacturing (CMC)-Formulation

3 official documents

Medication Guide ↗2026-01-08 · FDA document 84724
Label ↗2026-01-08 · FDA document 84723
Letter ↗2026-01-08 · FDA document 84715

2025-09-25 · status AP

Supplement 31

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

2 official documents

Label ↗2025-09-26 · FDA document 83555
Letter ↗2025-09-26 · FDA document 83542

2025-02-07 · status AP

Supplement 20

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

2 official documents

Label ↗2025-02-10 · FDA document 81191
Letter ↗2025-02-10 · FDA document 81181

2024-12-20 · status AP

Supplement 13

FDA action labels
Efficacy-New Indication

4 official documents

Review ↗2026-05-11 · FDA document 85860
Letter ↗2024-12-26 · FDA document 80713
Medication Guide ↗2024-12-20 · FDA document 80675
Label ↗2024-12-20 · FDA document 80674

2024-10-18 · status AP

Supplement 19

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

2 official documents

Label ↗2024-10-21 · FDA document 79938
Letter ↗2024-10-21 · FDA document 79930

2024-10-18 · status AP

Supplement 15

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

2 official documents

Label ↗2024-10-21 · FDA document 79952
Letter ↗2024-10-21 · FDA document 79929

2024-10-18 · status AP

Supplement 11

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2024-10-21 · FDA document 79937
Letter ↗2024-10-21 · FDA document 79928

2024-10-18 · status AP

Supplement 6

FDA action labels
Efficacy-Labeling Change With Clinical Data

2 official documents

Label ↗2024-10-21 · FDA document 79936
Letter ↗2024-10-21 · FDA document 79925

2024-10-18 · status AP

Supplement 5

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

3 official documents

Label ↗2024-10-21 · FDA document 79935
Letter ↗2024-10-21 · FDA document 79927
Letter ↗2024-10-21 · FDA document 79926

2024-03-28 · status AP

Supplement 3

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

2 official documents

Letter ↗2024-04-03 · FDA document 78043
Label ↗2024-04-01 · FDA document 78015

2023-11-08 · status AP

Original submission 1

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

3 official documents

Review ↗2024-04-16 · FDA document 78149
Letter ↗2023-11-13 · FDA document 76547
Label ↗2023-11-08 · FDA document 76538

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