Drugs@FDA application timeline

NDA218771

3 dated FDA-coded AP submissions from 2024-06-04 through 2026-08-03, connected to 4 source-defined action assignments and 8 official document links.

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3Dated AP submissions

4Action assignments

8Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Teriparatideteriparatide

Newest first

Submission and document chronology

3 submissions

2026-08-03 · status AP

Supplement 2

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

3 official documents

Medication Guide ↗2026-08-11 · FDA document 86858
Label ↗2026-08-11 · FDA document 86857
Letter ↗2026-08-06 · FDA document 86823

2025-01-23 · status AP

Supplement 1

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

2 official documents

Letter ↗2025-02-06 · FDA document 81103
Label ↗2025-02-06 · FDA document 81034

2024-06-04 · status AP

Original submission 1

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

3 official documents

Review ↗2025-02-04 · FDA document 80909
Letter ↗2024-07-02 · FDA document 78639
Label ↗2024-06-05 · FDA document 78650

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