2026-05-06 · status AP
Supplement 48
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
Drugs@FDA application timeline
ANDA075471
13 dated FDA-coded AP submissions from 2000-10-25 through 2026-05-06, connected to 15 source-defined action assignments and 1 official document links.
13Dated AP submissions
15Action assignments
1Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
2025-09-23 · status AP
Supplement 45
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2025-09-19 · status AP
Supplement 38
FDA action labels
Labeling-Package Insert · Labeling-Patient Package Insert
No eligible official document row was listed for this submission in the retained archive.
2025-09-19 · status AP
Supplement 37
FDA action labels
Labeling-Medication Guide · Labeling-Package Insert · Labeling-Patient Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-05-19 · status AP
Supplement 36
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 35
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 33
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2013-01-31 · status AP
Supplement 26
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2012-08-09 · status AP
Supplement 24
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-03-28 · status AP
Supplement 16
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2009-05-27 · status AP
Supplement 7
FDA action labels
Labeling
No eligible official document row was listed for this submission in the retained archive.
2001-09-20 · status AP
Supplement 1
FDA action labels
Manufacturing (CMC)-Control
No eligible official document row was listed for this submission in the retained archive.
2000-10-25 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Letter ↗2000-10-25 · FDA document 30899
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.