Toviaz
These highlights do not include all the information needed to use TOVIAZ safely and effectively. See full prescribing information for TOVIAZ. Toviaz (fesoterodine fumarate)For oral administrationInitial U.S. Approval: 2008
Approved
Approval ID
fead426f-b955-4b41-8553-f102d17afa3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 6, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6175
Application NumberNDA022030
Product Classification
M
Marketing Category
C73594
G
Generic Name
fesoterodine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateApril 6, 2012
FDA Product Classification
INGREDIENTS (13)
fesoterodine fumarateActive
Quantity: 8 mg in 1 1
Code: EOS72165S7
Classification: ACTIB
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
indigotindisulfonate sodiumInactive
Code: D3741U8K7L
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
lecithin, soybeanInactive
Code: 1DI56QDM62
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
xylitolInactive
Code: VCQ006KQ1E
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
fesoterodine fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6156
Application NumberNDA022030
Product Classification
M
Marketing Category
C73594
G
Generic Name
fesoterodine fumarate
Product Specifications
Route of AdministrationORAL
Effective DateApril 6, 2012
FDA Product Classification
INGREDIENTS (13)
fesoterodine fumarateActive
Quantity: 4 mg in 1 1
Code: EOS72165S7
Classification: ACTIB
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
indigotindisulfonate sodiumInactive
Code: D3741U8K7L
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
lecithin, soybeanInactive
Code: 1DI56QDM62
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
xylitolInactive
Code: VCQ006KQ1E
Classification: IACT