Drugs@FDA application timeline
BLA761412
1 dated FDA-coded AP submissions from 2026-04-29 through 2026-04-29, connected to 0 source-defined action assignments and 2 official document links.
1Dated AP submissions
0Action assignments
2Official documents
0Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Newest first
Submission and document chronology
1 submissions2026-04-29 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
2 official documents
- Letter ↗2026-05-01 · FDA document 85799
- Label ↗2026-05-01 · FDA document 85798
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.