2026-05-06 · status AP
Supplement 44
FDA action labels
Labeling-Package Insert
Drugs@FDA application timeline
NDA019010
35 dated FDA-coded AP submissions from 1985-04-09 through 2026-05-06, connected to 34 source-defined action assignments and 32 official document links.
35Dated AP submissions
34Action assignments
32Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-09-30 · status AP
Supplement 42
FDA action labels
Labeling-Package Insert
2025-09-23 · status AP
Supplement 43
FDA action labels
Labeling-Package Insert
2018-12-10 · status AP
Supplement 41
FDA action labels
Labeling-Package Insert
2017-07-11 · status AP
Supplement 39
FDA action labels
Labeling-Package Insert
2017-05-19 · status AP
Supplement 38
FDA action labels
Labeling-Package Insert
4 official documents
- Review ↗2018-04-18 · FDA document 53721
- Letter ↗2017-05-23 · FDA document 48497
- Medication Guide ↗2017-05-19 · FDA document 48467
- Label ↗2017-05-19 · FDA document 48466
2014-07-10 · status AP
Supplement 37
FDA action labels
Labeling-Package Insert
2011-03-21 · status AP
Supplement 35
FDA action labels
Labeling
2011-01-14 · status AP
Supplement 36
FDA action labels
Labeling
2010-04-28 · status AP
Supplement 33
FDA action labels
Labeling
2007-09-14 · status AP
Supplement 32
FDA action labels
Labeling
1 official document
- Letter ↗2007-09-25 · FDA document 1197
2005-09-15 · status AP
Supplement 31
FDA action labels
Labeling
2004-10-18 · status AP
Supplement 28
FDA action labels
Labeling
1 official document
- Letter ↗2004-10-22 · FDA document 1195
2003-11-25 · status AP
Supplement 27
FDA action labels
Labeling
1 official document
- Letter ↗2003-12-02 · FDA document 1194
2002-05-16 · status AP
Supplement 24
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2007-07-09 · FDA document 40859
2002-05-16 · status AP
Supplement 23
FDA action labels
Manufacturing (CMC)
1 official document
- Review ↗2007-07-09 · FDA document 40858
2000-12-21 · status AP
Supplement 22
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1999-11-22 · status AP
Supplement 21
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1998-09-25 · status AP
Supplement 20
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1998-01-08 · status AP
Supplement 19
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-07-07 · status AP
Supplement 18
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1997-07-07 · status AP
Supplement 17
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-05-28 · status AP
Supplement 15
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1996-04-24 · status AP
Supplement 14
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-05-09 · status AP
Supplement 12
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1994-05-09 · status AP
Supplement 11
FDA action labels
Manufacturing (CMC)
No eligible official document row was listed for this submission in the retained archive.
1993-06-09 · status AP
Supplement 10
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1992-07-07 · status AP
Supplement 9
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1991-10-21 · status AP
Supplement 8
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1988-05-09 · status AP
Supplement 6
FDA action labels
Manufacturing (CMC)-Formulation
1 official document
- Review ↗2007-07-09 · FDA document 20195
1988-01-19 · status AP
Supplement 3
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1987-03-12 · status AP
Supplement 4
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1987-01-14 · status AP
Supplement 5
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1986-07-10 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
1985-04-09 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
2 official documents
- Review ↗2019-02-15 · FDA document 57626
- Other Important Information from FDA ↗2011-12-20 · FDA document 23546
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.