REZLIDHIA
These highlights do not include all the information needed to use REZLIDHIA safely and effectively. See full prescribing information for REZLIDHIA. REZLIDHIA (olutasidenib) capsules, for oral useInitial U.S. Approval: 2022
Approved
Approval ID
4a0c7c8b-b95f-455d-9600-b7351e4397fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2023
Manufacturers
FDA
Rigel Pharmaceuticals, Inc.
DUNS: 967965468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olutasidenib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71332-005
Application NumberNDA215814
Product Classification
M
Marketing Category
C73594
G
Generic Name
olutasidenib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (9)
OLUTASIDENIBActive
Quantity: 150 mg in 1 1
Code: 0T4IMT8S5Z
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT