2026-01-21 · Class II · Ongoing
D-0290-2026 · Cipla USA, Inc.
Presence of Particulate Matter.
Open attributed report →Drugs@FDA application timeline
NDA215395
3 dated FDA-coded AP submissions from 2021-12-17 through 2024-09-16, connected to 2 source-defined action assignments and 7 official document links.
3Dated AP submissions
2Action assignments
7Official documents
2Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
2026-04-15 · Class II · Ongoing
D-0422-2026 · Cipla USA, Inc.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Open attributed report →Newest first
Submission and document chronology
2024-09-16 · status AP
Supplement 7
FDA action labels
Efficacy-New Indication
2024-07-11 · status AP
Supplement 8
FDA action labels
Labeling-Package Insert
2021-12-17 · 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.