2022-11-16 · Class I · Terminated
D-0058-2023 · Viatris Inc
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Open attributed report →Drugs@FDA application timeline
ANDA079198
10 dated FDA-coded AP submissions from 2011-02-10 through 2023-02-21, connected to 14 source-defined action assignments and 0 official document links.
10Dated AP submissions
14Action assignments
0Official 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
2023-02-21 · status AP
Supplement 13
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-02-21 · status AP
Supplement 11
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2023-02-21 · status AP
Supplement 10
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2019-09-05 · status AP
Supplement 7
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-07-07 · status AP
Supplement 6
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2017-07-07 · status AP
Supplement 5
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2013-05-23 · status AP
Supplement 3
FDA action labels
Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-12-02 · status AP
Supplement 2
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-07-14 · status AP
Supplement 1
FDA action labels
Labeling-Container/Carton Labels · Labeling-Package Insert
No eligible official document row was listed for this submission in the retained archive.
2011-02-10 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
No eligible official document row was listed for this submission in the retained archive.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.