2014-05-07 · Class II · Terminated
D-1289-2014 · AbbVie Inc
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →Drugs@FDA application timeline
NDA020263
41 dated FDA-coded AP submissions from 1993-04-16 through 2025-11-14, connected to 45 source-defined action assignments and 48 official document links.
41Dated AP submissions
45Action assignments
48Official documents
1Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
Newest first
Submission and document chronology
2025-11-14 · status AP
Supplement 57
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
3 official documents
- Letter ↗2025-11-18 · FDA document 84181
- Medication Guide ↗2025-11-17 · FDA document 84174
- Label ↗2025-11-17 · FDA document 84173
2025-09-23 · status AP
Supplement 58
FDA action labels
Labeling-Package Insert
2025-05-22 · status AP
Supplement 56
FDA action labels
Efficacy-Labeling Change With Clinical Data
2023-12-04 · status AP
Supplement 54
FDA action labels
Labeling-Container/Carton Labels
2023-04-14 · status AP
Supplement 53
FDA action labels
Efficacy-New Dosing Regimen
2022-04-22 · status AP
Supplement 50
FDA action labels
Labeling-Package Insert
2021-11-12 · status AP
Supplement 48
FDA action labels
Labeling-Container/Carton Labels
1 official document
- Letter ↗2021-11-15 · FDA document 69307
2021-03-11 · status AP
Supplement 47
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2021-03-11 · status AP
Supplement 44
FDA action labels
Labeling-Package Insert
2020-04-07 · status AP
Supplement 46
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert
2017-05-19 · status AP
Supplement 42
FDA action labels
Labeling-Package Insert · Labeling-Package Insert
2013-05-14 · status AP
Supplement 39
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
2011-10-08 · status AP
Supplement 37
FDA action labels
Efficacy-Labeling Change With Clinical Data
2011-08-15 · status AP
Supplement 36
FDA action labels
Efficacy-New Dosing Regimen
2010-08-30 · status AP
Supplement 35
FDA action labels
Labeling
2009-06-24 · status AP
Supplement 33
FDA action labels
Labeling
2008-07-31 · status AP
Supplement 30
FDA action labels
Labeling
1 official document
- Letter ↗2008-08-05 · FDA document 2267
2006-02-16 · status AP
Supplement 28
FDA action labels
Labeling
2005-11-09 · status AP
Supplement 26
FDA action labels
Manufacturing (CMC)-Control
2004-03-02 · status AP
Supplement 24
FDA action labels
Labeling
2003-12-23 · status AP
Supplement 23
FDA action labels
Labeling
1 official document
- Letter ↗2003-12-24 · FDA document 24687
2003-10-28 · status AP
Supplement 22
FDA action labels
Labeling
1 official document
- Letter ↗2003-10-31 · FDA document 24686
2002-09-24 · status AP
Supplement 20
FDA action labels
Manufacturing (CMC)-Control
1 official document
- Letter ↗2002-09-24 · FDA document 2265
2002-05-16 · status AP
Supplement 19
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-03-08 · status AP
Supplement 18
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-08-06 · status AP
Supplement 17
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-01-26 · status AP
Supplement 15
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-05-12 · status AP
Supplement 14
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-05-11 · status AP
Supplement 13
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1999-08-13 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2007-07-09 · FDA document 20576
1998-06-30 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-06-27 · status AP
Supplement 10
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-01-10 · status AP
Supplement 9
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1995-10-26 · status AP
Supplement 6
FDA action labels
Manufacturing (CMC)-Packaging
1 official document
- Review ↗2007-07-09 · FDA document 41252
1995-09-22 · status AP
Supplement 7
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1995-08-11 · status AP
Supplement 8
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1995-03-24 · status AP
Supplement 5
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1994-11-07 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-02-14 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)-Expiration Date
1 official document
- Review ↗2007-07-09 · FDA document 41251
1994-01-21 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1993-04-16 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Other Important Information from FDA ↗2011-12-20 · FDA document 44052
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.