2023-10-04 · Class III · Terminated
D-1178-2023 · Tolmar, Inc.
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Open attributed report →Drugs@FDA application timeline
NDA021379
22 dated FDA-coded AP submissions from 2002-07-24 through 2026-05-06, connected to 21 source-defined action assignments and 36 official document links.
22Dated AP submissions
21Action assignments
36Official 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
2026-05-06 · status AP
Supplement 65
FDA action labels
Labeling-Package Insert
2025-02-24 · status AP
Supplement 59
FDA action labels
Labeling-Package Insert
2025-02-04 · status AP
Supplement 58
FDA action labels
Labeling-Container/Carton Labels
2024-05-21 · status AP
Supplement 55
FDA action labels
Labeling-Container/Carton Labels
2024-01-23 · status AP
Supplement 53
FDA action labels
Labeling-Package Insert
2023-07-20 · status AP
Supplement 50
FDA action labels
Efficacy-New Indication
2023-07-20 · status AP
Supplement 49
FDA action labels
Efficacy-Labeling Change With Clinical Data
2019-02-15 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
2016-02-29 · status AP
Supplement 33
FDA action labels
Labeling-Package Insert
2014-10-10 · status AP
Supplement 30
FDA action labels
Labeling-Package Insert
2014-07-18 · status AP
Supplement 26
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-04-15 · status AP
Supplement 28
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2014-02-03 · status AP
Supplement 27
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-02-27 · status AP
Supplement 25
FDA action labels
Labeling-Package Insert
2013-02-08 · status AP
Supplement 23
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2013-01-25 · status AP
Supplement 22
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
2011-04-08 · status AP
Supplement 16
FDA action labels
Labeling-Package Insert
2011-01-14 · status AP
Supplement 15
FDA action labels
Labeling
2010-10-05 · status AP
Supplement 14
FDA action labels
Labeling-Package Insert
2007-11-08 · status AP
Supplement 10
FDA action labels
Labeling
2004-01-12 · status AP
Supplement 2
FDA action labels
Labeling
2002-07-24 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
4 official documents
- Other Important Information from FDA ↗2011-12-20 · FDA document 23652
- Review ↗2002-07-24 · FDA document 42130
- Label ↗2002-07-24 · FDA document 15342
- Letter ↗2002-07-24 · FDA document 5227
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.