FDA.reportPublic FDA data

Application 218033

Type
NDA
Sponsor
DAY ONE BIOPHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OJEMDATOVORAFENIBFOR SUSPENSION;ORAL25MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N218033-001OJEMDATOVORAFENIB25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218033-00182937522031-08-04Drug substance, Drug product2024-05-08
N218033-001104267822035-06-23Drug product2024-05-08

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218033-001NCE2029-04-23
N218033-001ODE-4782031-04-23

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
2026-09-14 22:38:342026-08N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-2384e616aacf4f…
2026-08-18 06:07:402026-07N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-238072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218033-001OJEMDA25MG/MLFOR SUSPENSION / ORALRLD, RS2024-04-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218033-00182937522031-08-04Drug substance, Drug product2024-05-0884e616aacf4f…
2026-09-14 22:38:342026-08N218033-001104267822035-06-23Drug product2024-05-0884e616aacf4f…
2026-08-18 06:07:402026-07N218033-00182937522031-08-04Drug substance, Drug product2024-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07N218033-001104267822035-06-23Drug product2024-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218033-00182937522031-08-04Drug substance, Drug product2024-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218033-001104267822035-06-23Drug product2024-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218033-00182937522031-08-04Drug substance, Drug product2024-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218033-001104267822035-06-23Drug product2024-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N218033-00182937522031-08-04Drug substance, Drug product2024-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218033-001104267822035-06-23Drug product2024-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218033-00182937522031-08-04Drug substance, Drug product2024-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218033-001104267822035-06-23Drug product2024-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218033-00182937522031-08-04Drug substance, Drug product2024-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218033-001104267822035-06-23Drug product2024-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218033-00182937522031-08-04Drug substance, Drug product2024-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218033-001104267822035-06-23Drug product2024-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218033-00182937522031-08-04Drug substance, Drug product2024-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218033-001104267822035-06-23Drug product2024-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218033-00182937522031-08-04Drug substance, Drug product2024-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218033-001104267822035-06-23Drug product2024-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218033-00182937522031-08-04Drug substance, Drug product2024-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218033-001104267822035-06-23Drug product2024-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218033-00182937522031-08-04Drug substance, Drug product2024-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N218033-001104267822035-06-23Drug product2024-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218033-00182937522031-08-04Drug substance, Drug product2024-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218033-001104267822035-06-23Drug product2024-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218033-00182937522031-08-04Drug substance, Drug product2024-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218033-001104267822035-06-23Drug product2024-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218033-00182937522031-08-04Drug substance, Drug product2024-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218033-001104267822035-06-23Drug product2024-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N218033-00182937522031-08-04Drug substance, Drug product2024-05-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05N218033-001104267822035-06-23Drug product2024-05-088072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218033-00182937522031-08-04Drug substance, Drug product2024-05-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218033-001104267822035-06-23Drug product2024-05-08a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218033-001NCE2029-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N218033-001ODE-4782031-04-2384e616aacf4f…
2026-08-18 06:07:402026-07N218033-001NCE2029-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N218033-001ODE-4782031-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218033-001NCE2029-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218033-001ODE-4782031-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218033-001NCE2029-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218033-001ODE-4782031-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N218033-001NCE2029-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218033-001ODE-4782031-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218033-001NCE2029-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218033-001ODE-4782031-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218033-001NCE2029-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218033-001ODE-4782031-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218033-001NCE2029-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218033-001ODE-4782031-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218033-001NCE2029-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218033-001ODE-4782031-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218033-001NCE2029-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218033-001ODE-4782031-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218033-001NCE2029-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218033-001ODE-4782031-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218033-001NCE2029-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N218033-001ODE-4782031-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218033-001NCE2029-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218033-001ODE-4782031-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218033-001NCE2029-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N218033-001ODE-4782031-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218033-001NCE2029-04-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N218033-001ODE-4782031-04-231e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218033-001NCE2029-04-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218033-001ODE-4782031-04-23a50c72e98297…

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
OJEMDATOVORAFENIBDay One Biopharmaceuticals, Inc.ea3a9631-3a66-6a7c-e053-2995a90ae2ad2025-09-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 218033
application number: NDA218033

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83233SUPPL 2025-08-29
83232SUPPL 2025-08-29
83221SUPPL 2025-08-28
83220SUPPL 2025-08-28
78919SUPPL 2024-06-27
78912SUPPL 2024-06-27
78554ORIG 2024-05-24
78538ORIG 2024-05-22
78535ORIG 2024-05-22