Drugs@FDA application timeline

NDA210134

3 dated FDA-coded AP submissions from 2019-07-24 through 2025-03-17, connected to 2 source-defined action assignments and 7 official document links.

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3Dated AP submissions

2Action assignments

7Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Glucagonglucagon

Newest first

Submission and document chronology

3 submissions

2025-03-17 · status AP

Supplement 4

FDA action labels
Efficacy-New Patient Population

2 official documents

Letter ↗2025-03-18 · FDA document 81633
Label ↗2025-03-18 · FDA document 81629

2020-10-27 · status AP

Supplement 2

FDA action labels
Labeling-Package Insert

2 official documents

Letter ↗2020-11-02 · FDA document 65120
Label ↗2020-10-29 · FDA document 65066

2019-07-24 · status AP

Original submission 1

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

3 official documents

Review ↗2019-11-25 · FDA document 61041
Letter ↗2019-07-25 · FDA document 59443
Label ↗2019-07-24 · FDA document 59441

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