Application 216354
- Type
- NDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 6MG | Yes | No |
| 002 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 12MG | Yes | No |
| 003 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 24MG | Yes | No |
| 004 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 005 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 36MG | Yes | No |
| 006 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 42MG | Yes | No |
| 007 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 48MG | Yes | Yes |
| 008 | AUSTEDO XR | DEUTETRABENAZINE | TABLET, EXTENDED RELEASE;ORAL | 18MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216354-001 | AUSTEDO XR | DEUTETRABENAZINE | 6MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | |
| N216354-002 | AUSTEDO XR | DEUTETRABENAZINE | 12MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | |
| N216354-003 | AUSTEDO XR | DEUTETRABENAZINE | 24MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | |
| N216354-004 | AUSTEDO XR | DEUTETRABENAZINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | |
| N216354-005 | AUSTEDO XR | DEUTETRABENAZINE | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | |
| N216354-006 | AUSTEDO XR | DEUTETRABENAZINE | 42MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | |
| N216354-007 | AUSTEDO XR | DEUTETRABENAZINE | 48MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-05-29 | |
| N216354-008 | AUSTEDO XR | DEUTETRABENAZINE | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-01 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216354-001 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2023-02-27 | |
| N216354-001 | 8524733*PED | 2031-10-03 | Pediatric extension | ||
| N216354-001 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2023-02-27 |
| N216354-001 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2023-02-27 |
| N216354-001 | 9550780*PED | 2034-03-18 | Pediatric extension | ||
| N216354-001 | 10959996 | 2036-03-07 | U-3055 | 2023-02-27 | |
| N216354-001 | 11357772 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-001 | 11357772 | 2036-03-07 | U-3055 | 2023-02-27 | |
| N216354-001 | 11446291 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-001 | 11564917 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-001 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | |
| N216354-001 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | |
| N216354-001 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | |
| N216354-001 | 10959996*PED | 2036-09-07 | Pediatric extension | ||
| N216354-001 | 11357772*PED | 2036-09-07 | Pediatric extension | ||
| N216354-001 | 11446291*PED | 2036-09-07 | Pediatric extension | ||
| N216354-001 | 11564917*PED | 2036-09-07 | Pediatric extension | ||
| N216354-001 | 11648244*PED | 2036-09-07 | Pediatric extension | ||
| N216354-001 | 12016858*PED | 2036-09-07 | Pediatric extension | ||
| N216354-001 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2023-02-27 |
| N216354-001 | 11179386 | 2038-03-15 | U-3055 | Drug product | 2023-02-27 |
| N216354-001 | 11813232 | 2038-03-15 | Drug product | 2023-12-07 | |
| N216354-001 | 11179386*PED | 2038-09-15 | Pediatric extension | ||
| N216354-001 | 11813232*PED | 2038-09-15 | Pediatric extension | ||
| N216354-001 | 11311488 | 2041-06-10 | U-1995 | Drug product | 2023-02-27 |
| N216354-001 | 11311488 | 2041-06-10 | U-3055 | Drug product | 2023-02-27 |
| N216354-001 | 12589075 | 2041-06-10 | U-1995 | 2026-04-29 | |
| N216354-001 | 12589075 | 2041-06-10 | U-3055 | 2026-04-29 | |
| N216354-001 | 12599598 | 2041-06-10 | U-1995 | 2026-04-29 | |
| N216354-001 | 12599598 | 2041-06-10 | U-3055 | 2026-04-29 | |
| N216354-002 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2023-02-27 | |
| N216354-002 | 8524733*PED | 2031-10-03 | Pediatric extension | ||
| N216354-002 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2023-02-27 |
| N216354-002 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2023-02-27 |
| N216354-002 | 9550780*PED | 2034-03-18 | Pediatric extension | ||
| N216354-002 | 10959996 | 2036-03-07 | U-3055 | 2023-02-27 | |
| N216354-002 | 11357772 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-002 | 11357772 | 2036-03-07 | U-3055 | 2023-02-27 | |
| N216354-002 | 11446291 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-002 | 11564917 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-002 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | |
| N216354-002 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | |
| N216354-002 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | |
| N216354-002 | 10959996*PED | 2036-09-07 | Pediatric extension | ||
| N216354-002 | 11357772*PED | 2036-09-07 | Pediatric extension | ||
| N216354-002 | 11446291*PED | 2036-09-07 | Pediatric extension | ||
| N216354-002 | 11564917*PED | 2036-09-07 | Pediatric extension | ||
| N216354-002 | 11648244*PED | 2036-09-07 | Pediatric extension | ||
| N216354-002 | 12016858*PED | 2036-09-07 | Pediatric extension | ||
| N216354-002 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2023-02-27 |
| N216354-002 | 11179386 | 2038-03-15 | U-3055 | Drug product | 2023-02-27 |
| N216354-002 | 11813232 | 2038-03-15 | Drug product | 2023-12-07 | |
| N216354-002 | 11179386*PED | 2038-09-15 | Pediatric extension | ||
| N216354-002 | 11813232*PED | 2038-09-15 | Pediatric extension | ||
| N216354-002 | 11311488 | 2041-06-10 | U-1995 | Drug product | 2023-02-27 |
| N216354-002 | 11311488 | 2041-06-10 | U-3055 | Drug product | 2023-02-27 |
| N216354-002 | 12589075 | 2041-06-10 | U-1995 | 2026-04-29 | |
| N216354-002 | 12589075 | 2041-06-10 | U-3055 | 2026-04-29 | |
| N216354-002 | 12599598 | 2041-06-10 | U-1995 | 2026-04-29 | |
| N216354-002 | 12599598 | 2041-06-10 | U-3055 | 2026-04-29 | |
| N216354-003 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2023-02-27 | |
| N216354-003 | 8524733*PED | 2031-10-03 | Pediatric extension | ||
| N216354-003 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2023-02-27 |
| N216354-003 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2023-02-27 |
| N216354-003 | 9550780*PED | 2034-03-18 | Pediatric extension | ||
| N216354-003 | 10959996 | 2036-03-07 | U-3055 | 2023-02-27 | |
| N216354-003 | 11357772 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-003 | 11357772 | 2036-03-07 | U-3055 | 2023-02-27 | |
| N216354-003 | 11446291 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-003 | 11564917 | 2036-03-07 | U-1995 | 2023-02-27 | |
| N216354-003 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | |
| N216354-003 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | |
| N216354-003 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | |
| N216354-003 | 10959996*PED | 2036-09-07 | Pediatric extension | ||
| N216354-003 | 11357772*PED | 2036-09-07 | Pediatric extension | ||
| N216354-003 | 11446291*PED | 2036-09-07 | Pediatric extension | ||
| N216354-003 | 11564917*PED | 2036-09-07 | Pediatric extension | ||
| N216354-003 | 11648244*PED | 2036-09-07 | Pediatric extension | ||
| N216354-003 | 12016858*PED | 2036-09-07 | Pediatric extension | ||
| N216354-003 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2023-02-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | AUSTEDO XR | 6MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | AUSTEDO XR | 12MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-003 | AUSTEDO XR | 24MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-004 | AUSTEDO XR | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-005 | AUSTEDO XR | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-006 | AUSTEDO XR | 42MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-007 | AUSTEDO XR | 48MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-05-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-008 | AUSTEDO XR | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-01 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-001 | AUSTEDO XR | 6MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-002 | AUSTEDO XR | 12MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-003 | AUSTEDO XR | 24MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-004 | AUSTEDO XR | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-005 | AUSTEDO XR | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-006 | AUSTEDO XR | 42MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-007 | AUSTEDO XR | 48MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216354-008 | AUSTEDO XR | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-001 | AUSTEDO XR | 6MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-002 | AUSTEDO XR | 12MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-003 | AUSTEDO XR | 24MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-004 | AUSTEDO XR | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-005 | AUSTEDO XR | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-006 | AUSTEDO XR | 42MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-007 | AUSTEDO XR | 48MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216354-008 | AUSTEDO XR | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-001 | AUSTEDO XR | 6MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-002 | AUSTEDO XR | 12MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-003 | AUSTEDO XR | 24MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-004 | AUSTEDO XR | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-005 | AUSTEDO XR | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-006 | AUSTEDO XR | 42MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-007 | AUSTEDO XR | 48MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-05-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216354-008 | AUSTEDO XR | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-001 | AUSTEDO XR | 6MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-002 | AUSTEDO XR | 12MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-003 | AUSTEDO XR | 24MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-004 | AUSTEDO XR | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-005 | AUSTEDO XR | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-006 | AUSTEDO XR | 42MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-007 | AUSTEDO XR | 48MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-05-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216354-008 | AUSTEDO XR | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-01 | 31067a03dcf5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 8524733*PED | 2031-10-03 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 9550780*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 10959996 | 2036-03-07 | U-3055 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11357772 | 2036-03-07 | U-1995 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11357772 | 2036-03-07 | U-3055 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11446291 | 2036-03-07 | U-1995 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11564917 | 2036-03-07 | U-1995 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 10959996*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11357772*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11446291*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11564917*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11648244*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12016858*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11179386 | 2038-03-15 | U-3055 | Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11813232 | 2038-03-15 | Drug product | 2023-12-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11179386*PED | 2038-09-15 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11813232*PED | 2038-09-15 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11311488 | 2041-06-10 | U-1995 | Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 11311488 | 2041-06-10 | U-3055 | Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12589075 | 2041-06-10 | U-3055 | 2026-04-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12589075 | 2041-06-10 | U-1995 | 2026-04-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12599598 | 2041-06-10 | U-3055 | 2026-04-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-001 | 12599598 | 2041-06-10 | U-1995 | 2026-04-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 8524733*PED | 2031-10-03 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2023-02-27 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 9550780*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 10959996 | 2036-03-07 | U-3055 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 11357772 | 2036-03-07 | U-3055 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 11357772 | 2036-03-07 | U-1995 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 11446291 | 2036-03-07 | U-1995 | 2023-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216354-002 | 11564917 | 2036-03-07 | U-1995 | 2023-02-27 | c2088c7a36db… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.