SOLIFENACINE SUCCINATE
These highlights do not include all the information needed to use SOLIFENACIN SUCCINATE TABLETS safely and effectively. See full prescribing information for SOLIFENACIN SUCCINATE TABLETS. SOLIFENACIN SUCCINATE tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
74d4f207-2a8c-47e6-81f4-1b52f5e35b99
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2022
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
solifenacine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-261
Application NumberANDA209839
Product Classification
M
Marketing Category
C73584
G
Generic Name
solifenacine succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
solifenacine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-259
Application NumberANDA209839
Product Classification
M
Marketing Category
C73584
G
Generic Name
solifenacine succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (11)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT