2025-03-25 · status AP
Supplement 20
No source action-type assignment was retained for this submission.
Drugs@FDA application timeline
BLA022505
12 dated FDA-coded AP submissions from 2010-11-10 through 2025-03-25, connected to 17 source-defined action assignments and 19 official document links.
12Dated AP submissions
17Action assignments
19Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2024-02-27 · status AP
Supplement 18
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert · Labeling-Patient Package Insert
2019-07-05 · status AP
Supplement 13
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert · Labeling-Patient Package Insert
2019-07-05 · status AP
Supplement 12
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert · Labeling-Patient Package Insert · Labeling-Proprietary Name Change
2019-01-18 · status AP
Supplement 11
FDA action labels
Labeling-Package Insert
2015-06-08 · status AP
Supplement 7
FDA action labels
Labeling-Package Insert
2015-02-09 · status AP
Supplement 6
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-12-15 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-01-07 · status AP
Supplement 4
FDA action labels
Labeling-Medication Guide
1 official document
- Label ↗2020-03-23 · FDA document 38773
2011-11-29 · status AP
Supplement 3
FDA action labels
Labeling-Patient Package Insert
1 official document
- Label ↗2020-03-23 · FDA document 17654
2011-11-29 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)
1 official document
- Label ↗2020-03-23 · FDA document 38772
2010-11-10 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Summary Review ↗2020-03-23 · FDA document 38771
- Review ↗2020-03-23 · FDA document 29793
- Label ↗2020-03-23 · FDA document 24327
- Letter ↗2020-03-23 · FDA document 22039
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.