Application 218466
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIJOICE | ALPELISIB | GRANULE;ORAL | 50MG/PACKET | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N218466-001 | VIJOICE | ALPELISIB | 50MG/PACKET | GRANULE / ORAL | RLD, RS | 2024-04-24 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | |
| N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | |
| N218466-001 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | |
| N218466-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 |
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 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULES / ORAL | RLD, RS | 2024-04-24 | 8072bd15b7f6… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218466-001 | VIJOICE | 50MG/PACKET | GRANULE / ORAL | RLD, RS | 2024-04-24 | a50c72e98297… |
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 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218466-001 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218466-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218466-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | 1e350fbaab3a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218466-001 | 8476268 | 2029-09-10 | Drug substance, Drug product | 2024-05-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218466-001 | 8227462 | 2033-04-29 | Drug substance, Drug product | 2024-05-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218466-001 | 11433059 | 2037-02-17 | U-4359 | 2025-12-22 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218466-001 | 12427141 | 2037-02-17 | U-4288 | 2025-10-20 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| VIJOICE | ALPELISIB | Novartis Pharmaceuticals Corporation | 638069a4-aee0-46c9-9e21-54ad449c163c | 2025-11-04 | Warnings, Adverse reactions | 218466 NDA218466 |