Application 216873
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | Yes | No |
| 002 | OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | Yes | No |
| 003 | OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216873-001 | OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | |
| N216873-002 | OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | |
| N216873-003 | OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216873-001 | 8486941 | 2035-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 |
| N216873-001 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | |
| N216873-001 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 |
| N216873-001 | 12576089 | 2039-08-21 | U-4441 | 2026-03-27 | |
| N216873-001 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | |
| N216873-002 | 8486941 | 2035-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 |
| N216873-002 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | |
| N216873-002 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 |
| N216873-002 | 12576089 | 2039-08-21 | U-4441 | 2026-03-27 | |
| N216873-002 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | |
| N216873-003 | 8486941 | 2035-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 |
| N216873-003 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | |
| N216873-003 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 |
| N216873-003 | 12576089 | 2039-08-21 | U-4441 | 2026-03-27 | |
| N216873-003 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N216873-001 | NCE | 2028-09-15 |
| N216873-001 | ODE-441 | 2030-09-15 |
| N216873-002 | NCE | 2028-09-15 |
| N216873-002 | ODE-441 | 2030-09-15 |
| N216873-003 | NCE | 2028-09-15 |
| N216873-003 | ODE-441 | 2030-09-15 |
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 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-002 | OJJAARA | EQ 150MG BASE | TABLET / ORAL | RLD | 2023-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-003 | OJJAARA | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 2023-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216873-001 | OJJAARA | EQ 100MG BASE | TABLET / ORAL | RLD | 2023-09-15 | 79d66fd596c7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-001 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-002 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-002 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-002 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-002 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-003 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-003 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-003 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216873-003 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-001 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-001 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-001 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-001 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-002 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-002 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-002 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-002 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-003 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-003 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-003 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216873-003 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-001 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-001 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-001 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-001 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-002 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-002 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-002 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-002 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-003 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-003 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-003 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216873-003 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-001 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-001 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-001 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-001 | 11963962 | 2040-12-02 | U-3928 | 2024-05-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-002 | 8486941 | 2030-01-03 | U-1201 | Drug substance, Drug product | 2023-10-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-002 | 9809559 | 2035-06-11 | U-1201 | 2023-10-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216873-002 | RE48285 | 2035-06-11 | U-1201 | Drug substance, Drug product | 2023-10-04 | d06236e962d9… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N216873-001 | NCE | 2028-09-15 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216873-001 | ODE-441 | 2030-09-15 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216873-002 | NCE | 2028-09-15 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216873-002 | ODE-441 | 2030-09-15 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216873-003 | NCE | 2028-09-15 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N216873-003 | ODE-441 | 2030-09-15 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N216873-001 | NCE | 2028-09-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N216873-001 | ODE-441 | 2030-09-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N216873-002 | NCE | 2028-09-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N216873-002 | ODE-441 | 2030-09-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N216873-003 | NCE | 2028-09-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N216873-003 | ODE-441 | 2030-09-15 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N216873-001 | NCE | 2028-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216873-001 | ODE-441 | 2030-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216873-002 | NCE | 2028-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216873-002 | ODE-441 | 2030-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216873-003 | NCE | 2028-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216873-003 | ODE-441 | 2030-09-15 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-001 | NCE | 2028-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-001 | ODE-441 | 2030-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-002 | NCE | 2028-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-002 | ODE-441 | 2030-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-003 | NCE | 2028-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216873-003 | ODE-441 | 2030-09-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-001 | NCE | 2028-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-001 | ODE-441 | 2030-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-002 | NCE | 2028-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-002 | ODE-441 | 2030-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-003 | NCE | 2028-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216873-003 | ODE-441 | 2030-09-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-001 | NCE | 2028-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-001 | ODE-441 | 2030-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-002 | NCE | 2028-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-002 | ODE-441 | 2030-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-003 | NCE | 2028-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216873-003 | ODE-441 | 2030-09-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-001 | NCE | 2028-09-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-001 | ODE-441 | 2030-09-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-002 | NCE | 2028-09-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216873-002 | ODE-441 | 2030-09-15 | fd3edfee7708… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ojjaara | MOMELOTINIB | GlaxoSmithKline LLC | 4a672fd1-eb7b-4aa9-9b23-845e4b5dc400 | 2026-07-20 | Warnings, Adverse reactions | 216873 NDA216873 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.