FDA.reportPublic FDA data

Application 219685

Type
NDA
Sponsor
GENZYME CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WAYRILZRILZABRUTINIBTABLET;ORAL400MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N219685-001WAYRILZRILZABRUTINIB400MGTABLET / ORALRLD, RS2025-08-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219685-00195804272033-03-01Drug substance, Drug product2025-09-25
N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25
N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25
N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25
N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25
N219685-001121788182040-10-13U-42672025-09-25
N219685-001117083702041-02-20Drug substance2025-09-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219685-001NCE2030-08-29
N219685-001ODE-5522032-08-29

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
2026-02-19 14:30 UTC2026-02N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001WAYRILZ400MGTABLET / ORALRLD, RS2025-08-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219685-00195804272033-03-01Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-001121788182040-10-13U-42672025-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219685-001117083702041-02-20Drug substance2025-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00195804272033-03-01Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001121788182040-10-13U-42672025-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001117083702041-02-20Drug substance2025-09-2531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00195804272033-03-01Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00189407442033-09-06U-4270Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00192668952033-09-06U-4268Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00199945762033-09-06U-4268Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-00199945762033-09-06U-4269Drug substance, Drug product2025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001121788182040-10-13U-42672025-09-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001117083702041-02-20Drug substance2025-09-25a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N219685-001NCE2030-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219685-001NCE2030-08-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001NCE2030-08-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219685-001ODE-5522032-08-29a50c72e98297…

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
WAYRILZRILZABRUTINIBGenzyme Corporation95ffd367-9b0c-4f75-8487-5d8f3c0a5ad02025-08-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 219685
application number: NDA219685

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83572ORIG 2025-09-29
83270ORIG 2025-09-03
83243ORIG 2025-09-02