Application 215559
- Type
- NDA
- Sponsor
- IPSEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 1MG | Yes | No |
| 002 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 1.5MG | Yes | No |
| 003 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 2.5MG | Yes | No |
| 004 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 5MG | Yes | No |
| 005 | SOHONOS | PALOVAROTENE | CAPSULE;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215559-001 | SOHONOS | PALOVAROTENE | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | |
| N215559-002 | SOHONOS | PALOVAROTENE | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | |
| N215559-003 | SOHONOS | PALOVAROTENE | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | |
| N215559-004 | SOHONOS | PALOVAROTENE | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | |
| N215559-005 | SOHONOS | PALOVAROTENE | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215559-001 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-001 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | |
| N215559-001 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-001 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-001 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-001 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-001 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | |
| N215559-001 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | |
| N215559-001 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | |
| N215559-002 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-002 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | |
| N215559-002 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-002 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-002 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-002 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-002 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | |
| N215559-002 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | |
| N215559-002 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | |
| N215559-003 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-003 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | |
| N215559-003 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-003 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-003 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-003 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-003 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | |
| N215559-003 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | |
| N215559-003 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | |
| N215559-004 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-004 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | |
| N215559-004 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-004 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-004 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-004 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-004 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | |
| N215559-004 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | |
| N215559-004 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | |
| N215559-005 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-005 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | |
| N215559-005 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-005 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | |
| N215559-005 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-005 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | |
| N215559-005 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | |
| N215559-005 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | |
| N215559-005 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N215559-001 | NCE | 2028-08-16 |
| N215559-001 | ODE-439 | 2030-08-16 |
| N215559-002 | NCE | 2028-08-16 |
| N215559-002 | ODE-439 | 2030-08-16 |
| N215559-003 | NCE | 2028-08-16 |
| N215559-003 | ODE-439 | 2030-08-16 |
| N215559-004 | NCE | 2028-08-16 |
| N215559-004 | ODE-439 | 2030-08-16 |
| N215559-005 | NCE | 2028-08-16 |
| N215559-005 | ODE-439 | 2030-08-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-001 | SOHONOS | 1MG | CAPSULE / ORAL | RLD | 2023-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-002 | SOHONOS | 1.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-003 | SOHONOS | 2.5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-004 | SOHONOS | 5MG | CAPSULE / ORAL | RLD | 2023-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-005 | SOHONOS | 10MG | CAPSULE / ORAL | RLD, RS | 2023-08-16 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-001 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-002 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-003 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 10864194 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 11622959 | 2037-06-08 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 12138245 | 2037-06-08 | U-4031 | 2024-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 12201614 | 2037-06-08 | U-4031 | 2025-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-004 | 12458626 | 2037-06-08 | U-3676 | 2025-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-005 | 10292954 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-005 | 12023312 | 2031-08-31 | U-3966 | 2024-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-005 | 9314439 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215559-005 | 9789074 | 2031-08-31 | U-3676 | 2023-09-07 | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N215559-001 | NCE | 2028-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-001 | ODE-439 | 2030-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-002 | NCE | 2028-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-002 | ODE-439 | 2030-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-003 | NCE | 2028-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-003 | ODE-439 | 2030-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-004 | NCE | 2028-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-004 | ODE-439 | 2030-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-005 | NCE | 2028-08-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215559-005 | ODE-439 | 2030-08-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-001 | NCE | 2028-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-001 | ODE-439 | 2030-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-002 | NCE | 2028-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-002 | ODE-439 | 2030-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-003 | NCE | 2028-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-003 | ODE-439 | 2030-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-004 | NCE | 2028-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-004 | ODE-439 | 2030-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-005 | NCE | 2028-08-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215559-005 | ODE-439 | 2030-08-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-001 | NCE | 2028-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-001 | ODE-439 | 2030-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-002 | NCE | 2028-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-002 | ODE-439 | 2030-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-003 | NCE | 2028-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-003 | ODE-439 | 2030-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-004 | NCE | 2028-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-004 | ODE-439 | 2030-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-005 | NCE | 2028-08-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215559-005 | ODE-439 | 2030-08-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-001 | NCE | 2028-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-001 | ODE-439 | 2030-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-002 | NCE | 2028-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-002 | ODE-439 | 2030-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-003 | NCE | 2028-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-003 | ODE-439 | 2030-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-004 | NCE | 2028-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-004 | ODE-439 | 2030-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-005 | NCE | 2028-08-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215559-005 | ODE-439 | 2030-08-16 | 03ed91905a0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.