2026-05-06 · status AP
Supplement 37
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA074728
15 dated FDA-coded AP submissions from 1998-08-04 through 2026-05-06, connected to 14 source-defined action assignments and 3 official document links.
15Dated AP submissions
14Action assignments
3Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2026-04-30 · status AP
Supplement 36
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2025-09-23 · status AP
Supplement 34
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2021-02-01 · status AP
Supplement 22
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2021-02-01 · status AP
Supplement 20
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-05-19 · status AP
Supplement 18
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-05-19 · status AP
Supplement 17
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2015-11-17 · status AP
Supplement 14
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-09-27 · status AP
Supplement 11
FDA action labels
Labeling-Package Insert
1 official document
- Label ↗2012-08-02 · FDA document 39437
2011-03-28 · status AP
Supplement 10
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2008-07-06 · status AP
Supplement 7
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2006-09-13 · status AP
Supplement 6
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-04-03 · status AP
Supplement 2
FDA action labels
Manufacturing (CMC)-Microbiology-Processing
No eligible official document row was listed for this submission in the retained archive.
1998-11-18 · status AP
Supplement 1
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
1998-08-04 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.