FDA.reportPublic FDA data

Application 218466

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIJOICEALPELISIBGRANULE;ORAL50MG/PACKETYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218466-001VIJOICEALPELISIB50MG/PACKETGRANULE / ORALRLD, RS2024-04-24

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218466-00184762682029-09-10Drug substance, Drug product2024-05-15
N218466-00182274622033-04-29Drug substance, Drug product2024-05-15
N218466-001114330592037-02-17U-43592025-12-22
N218466-001124271412037-02-17U-42882025-10-20

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N218466-001VIJOICE50MG/PACKETGRANULE / ORALRLD, RS2024-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N218466-001VIJOICE50MG/PACKETGRANULES / ORALRLD, RS2024-04-248072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218466-001VIJOICE50MG/PACKETGRANULE / ORALRLD, RS2024-04-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N218466-00184762682029-09-10Drug substance, Drug product2024-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07N218466-00182274622033-04-29Drug substance, Drug product2024-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07N218466-001114330592037-02-17U-43592025-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218466-001124271412037-02-17U-42882025-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218466-00184762682029-09-10Drug substance, Drug product2024-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218466-00182274622033-04-29Drug substance, Drug product2024-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218466-001114330592037-02-17U-43592025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218466-001124271412037-02-17U-42882025-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218466-00184762682029-09-10Drug substance, Drug product2024-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218466-00182274622033-04-29Drug substance, Drug product2024-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218466-001124271412037-02-17U-42882025-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N218466-00184762682029-09-10Drug substance, Drug product2024-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218466-00182274622033-04-29Drug substance, Drug product2024-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218466-00184762682029-09-10Drug substance, Drug product2024-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218466-00182274622033-04-29Drug substance, Drug product2024-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218466-00184762682029-09-10Drug substance, Drug product2024-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218466-00182274622033-04-29Drug substance, Drug product2024-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218466-00184762682029-09-10Drug substance, Drug product2024-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218466-00182274622033-04-29Drug substance, Drug product2024-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218466-00184762682029-09-10Drug substance, Drug product2024-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218466-00182274622033-04-29Drug substance, Drug product2024-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218466-00184762682029-09-10Drug substance, Drug product2024-05-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218466-00182274622033-04-29Drug substance, Drug product2024-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218466-00184762682029-09-10Drug substance, Drug product2024-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218466-00182274622033-04-29Drug substance, Drug product2024-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218466-00184762682029-09-10Drug substance, Drug product2024-05-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N218466-00182274622033-04-29Drug substance, Drug product2024-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218466-00184762682029-09-10Drug substance, Drug product2024-05-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218466-00182274622033-04-29Drug substance, Drug product2024-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218466-00184762682029-09-10Drug substance, Drug product2024-05-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218466-00182274622033-04-29Drug substance, Drug product2024-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218466-00184762682029-09-10Drug substance, Drug product2024-05-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218466-00182274622033-04-29Drug substance, Drug product2024-05-151e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218466-00184762682029-09-10Drug substance, Drug product2024-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218466-00182274622033-04-29Drug substance, Drug product2024-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218466-001114330592037-02-17U-43592025-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218466-001124271412037-02-17U-42882025-10-20a50c72e98297…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIJOICEALPELISIBNovartis Pharmaceuticals Corporation638069a4-aee0-46c9-9e21-54ad449c163c2025-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 218466
application number: NDA218466

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82915SUPPL 2025-07-24
82912SUPPL 2025-07-23
81920ORIG 2025-04-10
78259ORIG 2024-04-25
78247ORIG 2024-04-25