Fesoterodine Fumarate
These highlights do not include all the information needed to use FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS. FESOTERODINE FUMARATE extended-release tablets, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
b1abd9cb-c480-437b-8531-e2de3e188363
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2022
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-068
Application NumberANDA204827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fesoterodine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FESOTERODINE FUMARATEActive
Quantity: 8 mg in 1 1
Code: EOS72165S7
Classification: ACTIB
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
Fesoterodine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-064
Application NumberANDA204827
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fesoterodine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (10)
FESOTERODINE FUMARATEActive
Quantity: 4 mg in 1 1
Code: EOS72165S7
Classification: ACTIB
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT