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
NDC Product Code54868-6175
Application NumberNDA022030
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 6, 2012
Generic Namefesoterodine fumarate
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
NDC Product Code54868-6156
Application NumberNDA022030
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 6, 2012
Generic Namefesoterodine fumarate
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