Rezurock
These highlights do not include all the information needed to use REZUROCK safely and effectively. See full prescribing information for REZUROCK. REZUROCK (belumosudil) tablets, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
102e4ef4-7f84-4e34-8df1-479c24d1575d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Kadmon Pharmaceuticals, LLC
DUNS: 117510981
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
belumosudil
PRODUCT DETAILS
NDC Product Code79802-200
Application NumberNDA214783
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 16, 2023
Generic Namebelumosudil
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BELUMOSUDILActive
Quantity: 200 mg in 1 1
Code: 834YJF89WO
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT