Daurismo
These highlights do not include all the information needed to use DAURISMO safely and effectively. See full prescribing information for DAURISMO. DAURISMO™ (glasdegib) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
204a6f7e-c9a4-472b-abd2-9527bda64d17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
glasdegib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0298
Application NumberNDA210656
Product Classification
M
Marketing Category
C73594
G
Generic Name
glasdegib
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2023
FDA Product Classification
INGREDIENTS (12)
GLASDEGIBActive
Quantity: 25 mg in 1 1
Code: K673DMO5H9
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
glasdegib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-1531
Application NumberNDA210656
Product Classification
M
Marketing Category
C73594
G
Generic Name
glasdegib
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2023
FDA Product Classification
INGREDIENTS (12)
GLASDEGIBActive
Quantity: 100 mg in 1 1
Code: K673DMO5H9
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT