Drugs@FDA application timeline

NDA021332

11 dated FDA-coded AP submissions from 2005-03-16 through 2019-12-18, connected to 11 source-defined action assignments and 20 official document links.

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11Dated AP submissions

11Action assignments

20Official documents

0Exact enforcement reports

1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Pramlintidepramlintide acetate

Newest first

Submission and document chronology

11 submissions

2019-12-18 · status AP

Supplement 28

FDA action labels
Labeling-Package Insert

2 official documents

Letter ↗2019-12-23 · FDA document 61383
Label ↗2019-12-19 · FDA document 61358

2017-03-08 · status AP

Supplement 26

FDA action labels
REMS - MODIFIED - D-N-A

1 official document

Letter ↗2017-03-14 · FDA document 47544

2015-08-07 · status AP

Supplement 24

FDA action labels
Labeling-Package Insert

1 official document

Letter ↗2015-08-11 · FDA document 27501

2015-03-20 · status AP

Supplement 25

FDA action labels
Labeling-Package Insert

2 official documents

Letter ↗2015-04-13 · FDA document 27502
Label ↗2015-03-24 · FDA document 36673

2015-02-25 · status AP

Supplement 23

FDA action labels
Labeling-Container/Carton Labels

2 official documents

Label ↗2015-03-03 · FDA document 15206
Letter ↗2015-02-27 · FDA document 5062

2014-06-27 · status AP

Supplement 16

FDA action labels
Labeling-Package Insert

2 official documents

Label ↗2014-07-01 · FDA document 36672
Letter ↗2014-06-30 · FDA document 27499

2014-06-27 · status AP

Supplement 7

FDA action labels
Efficacy-Labeling Change With Clinical Data

2 official documents

Label ↗2014-07-01 · FDA document 15205
Letter ↗2014-06-30 · FDA document 5060

2012-01-03 · status AP

Supplement 20

FDA action labels
Labeling-Container/Carton Labels

1 official document

Letter ↗2012-01-05 · FDA document 27500

2008-08-04 · status AP

Supplement 10

FDA action labels
Labeling

1 official document

Letter ↗2008-08-06 · FDA document 5061

2007-09-25 · status AP

Supplement 6

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

2 official documents

Letter ↗2007-10-04 · FDA document 27498
Label ↗2007-09-26 · FDA document 36671

2005-03-16 · status AP

Original submission 1

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

4 official documents

Medication Guide ↗2007-02-28 · FDA document 23256
Review ↗2005-06-14 · FDA document 42103
Label ↗2005-03-18 · FDA document 36670
Letter ↗2005-03-18 · FDA document 5059

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