FDA.reportPublic FDA data

Application 220375

Type
ANDA
Sponsor
TORRENT PHARMACEUTICALS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002RUXOLITINIBRUXOLITINIBTABLET20MGNoNo
003RUXOLITINIBRUXOLITINIBTABLET15MGNoNo
004RUXOLITINIBRUXOLITINIBTABLET10MGNoNo
005RUXOLITINIBRUXOLITINIBTABLET5MGNoNo

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