Drugs@FDA application timeline

NDA208743

11 dated FDA-coded AP submissions from 2017-04-28 through 2026-08-03, connected to 12 source-defined action assignments and 23 official document links.

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11Dated AP submissions

12Action assignments

23Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Abaloparatideabaloparatide

Newest first

Submission and document chronology

11 submissions

2026-08-03 · status AP

Supplement 18

FDA action labels
Labeling-Package Insert

3 official documents

Medication Guide ↗2026-08-11 · FDA document 86855
Label ↗2026-08-11 · FDA document 86852
Letter ↗2026-08-06 · FDA document 86821

2025-03-28 · status AP

Supplement 17

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2026-03-02 · FDA document 84393
Letter ↗2025-04-09 · FDA document 81894

2023-12-21 · status AP

Supplement 15

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

2 official documents

Label ↗2023-12-27 · FDA document 77142
Letter ↗2023-12-27 · FDA document 77113

2022-12-19 · status AP

Supplement 13

FDA action labels
Efficacy-New Indication

1 official document

Label ↗2022-12-21 · FDA document 72967

2021-12-22 · status AP

Supplement 10

FDA action labels
Efficacy-Labeling Change With Clinical Data

1 official document

Label ↗2021-12-23 · FDA document 69754

2021-09-20 · status AP

Supplement 9

FDA action labels
Efficacy-Labeling Change With Clinical Data

2 official documents

Letter ↗2021-09-21 · FDA document 68695
Label ↗2021-09-21 · FDA document 68681

2020-10-23 · status AP

Supplement 7

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2020-10-27 · FDA document 65037
Letter ↗2020-10-27 · FDA document 65033

2018-10-17 · status AP

Supplement 3

FDA action labels
Efficacy-Labeling Change With Clinical Data

2 official documents

Letter ↗2018-10-23 · FDA document 56059
Label ↗2018-10-18 · FDA document 56014

2018-06-20 · status AP

Supplement 4

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2018-07-04 · FDA document 54745
Letter ↗2018-06-27 · FDA document 54704

2018-02-05 · status AP

Supplement 1

FDA action labels
Labeling-Package Insert

2 official documents

Letter ↗2018-02-09 · FDA document 52539
Label ↗2018-02-05 · FDA document 52396

2017-04-28 · status AP

Original submission 1

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

4 official documents

Summary Review ↗2017-06-08 · FDA document 48681
Review ↗2017-06-08 · FDA document 48680
Letter ↗2017-04-28 · FDA document 48158
Label ↗2017-04-28 · FDA document 48157

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