Regulatory › Drugs@FDA › History › NDA022341 Drugs@FDA application timeline
NDA022341 29 dated FDA-coded AP submissions from 2010-01-25 through 2025-10-14, connected to 35 source-defined action assignments and 52 official document links.
29 Dated AP submissions
35 Action assignments
52 Official documents
1 Exact enforcement reports
1 Reviewed profile mappings
Reporting boundary This history reports exact Drugs@FDA submission status dates, source-defined action labels, and official document metadata for applications already selected by PeptideScanner. FDA's AP code and action labels are source metadata; this page does not interpret approval scope, reproduce document text, establish safety or effectiveness, or provide medical guidance. Document links open FDA-hosted material; PeptideScanner does not copy or summarize their contents.
Reviewed identity mapping
Connected peptide profiles Reporting boundary This PeptideScanner lane is a bounded, dated FDA enforcement-report snapshot connected through an exact openFDA application-number annotation. It is not a medical alert or complete recall-lifecycle tracker, does not establish current product or recall status, does not identify affected lots, and does not provide medical guidance.
2021-04-21 · Class II · Terminated
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Open attributed report → Newest first
Submission and document chronology 29 submissions 2025-10-14 · status AP
Supplement 46 FDA action labels
3 official documents 2025-05-28 · status AP
Supplement 44 FDA action labels
1 official document Label ↗ 2025-05-30 · FDA document 82371 2025-02-12 · status AP
Supplement 42 FDA action labels
2 official documents Label ↗ 2025-02-21 · FDA document 81252 Letter ↗ 2025-02-13 · FDA document 81237 2024-11-01 · status AP
Supplement 43 FDA action labels
2 official documents Letter ↗ 2024-11-01 · FDA document 80065 Label ↗ 2024-11-01 · FDA document 80064 2023-07-05 · status AP
Supplement 39 FDA action labels
2 official documents Letter ↗ 2023-07-07 · FDA document 74710 Label ↗ 2023-07-06 · FDA document 74703 2022-06-10 · status AP
Supplement 38 FDA action labels
2 official documents Label ↗ 2022-06-15 · FDA document 71327 Letter ↗ 2022-06-13 · FDA document 71280 2022-06-10 · status AP
Supplement 37 FDA action labels
1 official document 2020-11-20 · status AP
Supplement 36 FDA action labels
2 official documents Label ↗ 2020-11-25 · FDA document 65317 Letter ↗ 2020-11-25 · FDA document 65307 2020-08-05 · status AP
Supplement 35 FDA action labels
2 official documents Letter ↗ 2020-08-06 · FDA document 64220 Label ↗ 2020-08-06 · FDA document 64211 2019-06-17 · status AP
Supplement 31 FDA action labels
2 official documents Label ↗ 2019-06-21 · FDA document 59151 Letter ↗ 2019-06-18 · FDA document 59110 2017-08-25 · status AP
Supplement 27 FDA action labels
3 official documents Review ↗ 2020-07-22 · FDA document 64010 Label ↗ 2017-08-28 · FDA document 49554 Letter ↗ 2017-08-28 · FDA document 49547 2017-07-26 · status AP
Supplement 29 FDA action labels
1 official document 2017-04-25 · status AP
Supplement 28 FDA action labels
2 official documents Letter ↗ 2017-04-27 · FDA document 48151 Label ↗ 2017-04-26 · FDA document 48119 2016-09-20 · status AP
Supplement 26 FDA action labels
1 official document 2016-04-22 · status AP
Supplement 25 FDA action labels
2 official documents Label ↗ 2016-04-27 · FDA document 17275 Letter ↗ 2016-04-26 · FDA document 7270 2015-07-01 · status AP
Supplement 24 FDA action labels
1 official document 2015-03-09 · status AP
Supplement 23 FDA action labels
2 official documents Label ↗ 2015-03-26 · FDA document 17274 Letter ↗ 2015-03-11 · FDA document 7269 2015-02-25 · status AP
Supplement 22 FDA action labels
2 official documents Label ↗ 2015-03-03 · FDA document 38603 Letter ↗ 2015-02-27 · FDA document 7268 2014-07-31 · status AP
Supplement 21 FDA action labels
1 official document 2013-06-13 · status AP
Supplement 20 FDA action labels
2 official documents Label ↗ 2013-06-18 · FDA document 38602 Letter ↗ 2013-06-14 · FDA document 7267 2013-04-16 · status AP
Supplement 18 FDA action labels
2 official documents Letter ↗ 2013-04-18 · FDA document 29623 Label ↗ 2013-04-17 · FDA document 17273 2012-12-13 · status AP
Supplement 17 FDA action labels
2 official documents Letter ↗ 2012-12-19 · FDA document 29622 Label ↗ 2012-12-18 · FDA document 17272 2012-12-03 · status AP
Supplement 10 FDA action labels
No eligible official document row was listed for this submission in the retained archive.
2012-04-06 · status AP
Supplement 13 FDA action labels
2 official documents Label ↗ 2012-04-09 · FDA document 38601 Letter ↗ 2012-04-09 · FDA document 7266 2012-04-06 · status AP
Supplement 9 FDA action labels
2 official documents Letter ↗ 2012-04-09 · FDA document 29621 Label ↗ 2012-04-09 · FDA document 17271 2012-04-06 · status AP
Supplement 7 FDA action labels
2 official documents Label ↗ 2012-04-09 · FDA document 38600 Letter ↗ 2012-04-09 · FDA document 7265 2011-05-18 · status AP
Supplement 4 FDA action labels
2 official documents Letter ↗ 2011-05-24 · FDA document 29620 Label ↗ 2011-05-23 · FDA document 38599 2010-12-22 · status AP
Supplement 1 FDA action labels
1 official document Label ↗ 2010-12-26 · FDA document 38598 2010-01-25 · status AP
Original submission 1 No source action-type assignment was retained for this submission.
3 official documents Review ↗ 2010-04-06 · FDA document 42495 Letter ↗ 2010-01-26 · FDA document 29619 Label ↗ 2010-01-26 · FDA document 17270 Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.