FDA.reportPublic FDA data

Application 219660

Type
NDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002RuxolitinibRuxolitinibTABLET; ORAL10MGNoNo
003RuxolitinibRuxolitinibTABLET; ORAL15MGNoNo
004RuxolitinibRuxolitinibTABLET; ORAL2MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAKAFIRUXOLITINIBIncyte Corporationf1c82580-87ae-11e0-bc84-0002a5d5c51b2026-07-20Warnings, Adverse reactionsName fallback
generic name: RUXOLITINIB
OPZELURARUXOLITINIBIncyte Corporation24da5509-6631-4795-9d42-273faecd08e72026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RUXOLITINIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84285ORIG 2025-11-24