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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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