2014-05-07 · Class II · Terminated
D-1290-2014 · 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
NDA020708
31 dated FDA-coded AP submissions from 1997-03-07 through 2025-09-10, connected to 30 source-defined action assignments and 37 official document links.
31Dated AP submissions
30Action assignments
37Official 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
2025-09-10 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
2025-09-10 · status AP
Supplement 40
FDA action labels
Labeling-Package Insert
2020-03-18 · status AP
Supplement 38
FDA action labels
Labeling-Package Insert
2018-04-18 · status AP
Supplement 35
FDA action labels
Labeling-Package Insert
2013-10-30 · status AP
Supplement 34
FDA action labels
Labeling-Patient Package Insert
2012-03-28 · status AP
Supplement 31
FDA action labels
Labeling
2012-01-23 · status AP
Supplement 33
FDA action labels
Labeling-Package Insert
2011-06-14 · status AP
Supplement 32
FDA action labels
Labeling-Package Insert
2010-10-29 · status AP
Supplement 30
FDA action labels
Labeling
2009-06-02 · status AP
Supplement 29
FDA action labels
Labeling
2007-10-31 · status AP
Supplement 26
FDA action labels
Labeling
1 official document
- Letter ↗2007-11-08 · FDA document 3149
2005-09-15 · status AP
Supplement 21
FDA action labels
Labeling
2005-09-15 · status AP
Supplement 20
FDA action labels
Manufacturing (CMC)-Control
2004-01-15 · status AP
Supplement 15
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-22 · FDA document 3147
2004-01-12 · status AP
Supplement 18
FDA action labels
Labeling
1 official document
- Letter ↗2004-01-14 · FDA document 25585
2002-09-20 · status AP
Supplement 16
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 14
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-11-14 · status AP
Supplement 13
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-09-21 · status AP
Supplement 11
FDA action labels
Efficacy-New Indication
2001-07-23 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2001-03-01 · 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 41596
1999-02-11 · status AP
Supplement 5
FDA action labels
Efficacy-Labeling Change With Clinical Data
1998-07-29 · status AP
Supplement 4
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1998-04-09 · status AP
Supplement 3
FDA action labels
Labeling
1997-12-23 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-09-04 · status AP
Supplement 1
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1997-03-07 · 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 44066
- Review ↗2003-08-08 · FDA document 20864
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.