2026-07-08 · Class II · Ongoing
D-0723-2026 · Lupin Pharmaceuticals Inc.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Open attributed report →Drugs@FDA application timeline
ANDA214457
1 dated FDA-coded AP submissions from 2025-07-22 through 2025-07-22, connected to 0 source-defined action assignments and 0 official document links.
1Dated AP submissions
0Action assignments
0Official documents
1Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
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Submission and document chronology
2025-07-22 · 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.