CALQUENCE
These highlights do not include all the information needed to use CALQUENCE safely and effectively. See full prescribing information for CALQUENCE.CALQUENCE (acalabrutinib) tablets, for oral useInitial U.S. Approval: 2017
Approved
Approval ID
b1409184-3267-4d8c-8f17-4e01f69828b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acalabrutinib
PRODUCT DETAILS
NDC Product Code0310-3512
Application NumberNDA216387
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 4, 2022
Generic Nameacalabrutinib
INGREDIENTS (13)
ACALABRUTINIBActive
Quantity: 100 mg in 1 1
Code: I42748ELQW
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT