2014-05-07 · Class II · Terminated
D-1287-2014 · 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
NDA020517
36 dated FDA-coded AP submissions from 1995-12-22 through 2025-08-18, connected to 36 source-defined action assignments and 48 official document links.
36Dated AP submissions
36Action assignments
48Official documents
3Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
2014-05-07 · Class II · Terminated
D-1288-2014 · 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 →2014-05-07 · Class II · Terminated
D-1291-2014 · AbbVie Inc
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →Newest first
Submission and document chronology
2025-08-18 · status AP
Supplement 47
FDA action labels
Labeling-Package Insert
2024-03-21 · status AP
Supplement 46
FDA action labels
Labeling-Package Insert
2023-12-04 · status AP
Supplement 45
FDA action labels
Labeling-Package Insert
2022-04-18 · status AP
Supplement 43
FDA action labels
Efficacy-New Indication
2019-03-04 · status AP
Supplement 42
FDA action labels
Labeling-Package Insert
2018-12-10 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
2016-06-06 · status AP
Supplement 38
FDA action labels
Labeling-Package Insert
2016-02-11 · status AP
Supplement 37
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-06-27 · status AP
Supplement 36
FDA action labels
Labeling-Package Insert
2013-11-08 · status AP
Supplement 34
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-07-10 · status AP
Supplement 35
FDA action labels
Labeling-Package Insert
2012-07-18 · status AP
Supplement 33
FDA action labels
Labeling-Package Insert
2011-06-17 · status AP
Supplement 32
FDA action labels
Labeling · Labeling-Package Insert
2011-06-17 · status AP
Supplement 30
FDA action labels
Efficacy-New Dosing Regimen
2011-06-17 · status AP
Supplement 25
FDA action labels
Labeling
2011-01-14 · status AP
Supplement 31
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 29
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 28
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 24
FDA action labels
Labeling
2005-09-15 · status AP
Supplement 19
FDA action labels
Labeling
2005-09-15 · status AP
Supplement 18
FDA action labels
Manufacturing (CMC)-Control
2004-01-12 · status AP
Supplement 16
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 2643
2003-09-09 · status AP
Supplement 13
FDA action labels
Labeling
1 official document
- Letter ↗2003-09-25 · FDA document 25084
2002-09-20 · status AP
Supplement 14
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2002-05-23 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-07-23 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-03-01 · status AP
Supplement 10
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-01-24 · status AP
Supplement 9
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 8
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 7
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 6
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2007-07-09 · FDA document 20694
1998-07-29 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-12-23 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-05-30 · status AP
Supplement 2
FDA action labels
Efficacy-New Dosing Regimen
1 official document
- Review ↗1997-05-30 · FDA document 20693
1996-12-03 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)-Packaging
1 official document
- Review ↗2006-03-30 · FDA document 41405
1995-12-22 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
2 official documents
- Other Important Information from FDA ↗2011-12-20 · FDA document 23581
- Review ↗2006-04-06 · FDA document 20692
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.