Drugs@FDA application timeline

NDA211939

4 dated FDA-coded AP submissions from 2019-10-04 through 2026-08-03, connected to 5 source-defined action assignments and 10 official document links.

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4Dated AP submissions

5Action assignments

10Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Teriparatideteriparatide

Newest first

Submission and document chronology

4 submissions

2026-08-03 · status AP

Supplement 21

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

3 official documents

Medication Guide ↗2026-08-11 · FDA document 86856
Label ↗2026-08-11 · FDA document 86853
Letter ↗2026-08-06 · FDA document 86825

2025-01-24 · status AP

Supplement 17

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

2 official documents

Letter ↗2025-02-06 · FDA document 81092
Label ↗2025-02-06 · FDA document 81035

2023-11-16 · status AP

Supplement 4

FDA action labels
Efficacy-Labeling Change With Clinical Data

2 official documents

Letter ↗2023-11-17 · FDA document 76618
Label ↗2023-11-17 · FDA document 76603

2019-10-04 · status AP

Original submission 1

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

3 official documents

Review ↗2020-02-26 · FDA document 61966
Letter ↗2019-10-07 · FDA document 60263
Label ↗2019-10-07 · FDA document 60249

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