Application 215039
- Type
- NDA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIJOICE | ALPELISIB | TABLET; ORAL | 50MG | No | No |
| 002 | VIJOICE | ALPELISIB | TABLET; ORAL | 125MG | No | No |
| 003 | VIJOICE | ALPELISIB | TABLET; ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215039-001 | VIJOICE | ALPELISIB | 50MG | TABLET / ORAL | RLD | 2022-04-05 | |
| N215039-002 | VIJOICE | ALPELISIB | 125MG | TABLET / ORAL | RLD | 2022-04-05 | |
| N215039-003 | VIJOICE | ALPELISIB | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | |
| N215039-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | |
| N215039-001 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | |
| N215039-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | |
| N215039-002 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | |
| N215039-002 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | |
| N215039-002 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | |
| N215039-002 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | |
| N215039-003 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | |
| N215039-003 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | |
| N215039-003 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | |
| N215039-003 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N215039-001 | ODE-396 | 2029-04-05 |
| N215039-002 | ODE-396 | 2029-04-05 |
| N215039-003 | ODE-396 | 2029-04-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215039-002 | VIJOICE | 125MG | TABLET / ORAL | RLD | 2022-04-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215039-003 | VIJOICE | 200MG | TABLET / ORAL | RLD, RS | 2022-04-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215039-001 | VIJOICE | 50MG | TABLET / ORAL | RLD | 2022-04-05 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-001 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-002 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-002 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-002 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-002 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-003 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-003 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-003 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-003 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-002 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-002 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-002 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-003 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-003 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-003 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-002 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-002 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-003 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-003 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-002 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-002 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-003 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-003 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-002 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-002 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-003 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-003 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2022-05-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2022-05-03 | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215039-001 | ODE-396 | 2029-04-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-002 | ODE-396 | 2029-04-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215039-003 | ODE-396 | 2029-04-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-001 | ODE-396 | 2029-04-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-002 | ODE-396 | 2029-04-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215039-003 | ODE-396 | 2029-04-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-001 | ODE-396 | 2029-04-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-002 | ODE-396 | 2029-04-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215039-003 | ODE-396 | 2029-04-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-001 | ODE-396 | 2029-04-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-002 | ODE-396 | 2029-04-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215039-003 | ODE-396 | 2029-04-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-001 | ODE-396 | 2029-04-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-002 | ODE-396 | 2029-04-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215039-003 | ODE-396 | 2029-04-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-001 | NCE | 2024-05-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-001 | ODE-396 | 2029-04-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-002 | NCE | 2024-05-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-002 | ODE-396 | 2029-04-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-003 | NCE | 2024-05-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215039-003 | ODE-396 | 2029-04-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-001 | NCE | 2024-05-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-001 | ODE-396 | 2029-04-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-002 | NCE | 2024-05-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-002 | ODE-396 | 2029-04-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-003 | NCE | 2024-05-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215039-003 | ODE-396 | 2029-04-05 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-001 | NCE | 2024-05-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-001 | ODE-396 | 2029-04-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-002 | NCE | 2024-05-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-002 | ODE-396 | 2029-04-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-003 | NCE | 2024-05-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215039-003 | ODE-396 | 2029-04-05 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-001 | NCE | 2024-05-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-001 | ODE-396 | 2029-04-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-002 | NCE | 2024-05-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-002 | ODE-396 | 2029-04-05 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-003 | NCE | 2024-05-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215039-003 | ODE-396 | 2029-04-05 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N215039-001 | NCE | 2024-05-24 | d06236e962d9… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-1021 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1021 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1021 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1028 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1028 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1028 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1035 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1035 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1035 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |