Fesoterodine Fumarate
Fesoterodine fumarate extended-release tablets, for oral use Initial U.S. Approval: 2008 These highlights do not include all the information needed to use fesoterodine fumarate safely and effectively. See full prescribing information for fesoterodine fumarate.
Approved
Approval ID
099619f5-a4d8-b09a-e063-6294a90a3cb5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fesoterodine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-053
Application NumberANDA205002
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fesoterodine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (12)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FESOTERODINE FUMARATEActive
Quantity: 4 mg in 1 1
Code: EOS72165S7
Classification: ACTIB
Fesoterodine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-054
Application NumberANDA205002
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fesoterodine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (12)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FESOTERODINE FUMARATEActive
Quantity: 8 mg in 1 1
Code: EOS72165S7
Classification: ACTIB