Solifenacin 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 use Initial U.S. Approval: 2004
Approved
Approval ID
48f82298-6600-4c69-a638-8dae15083fd9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2021
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Solifenacin Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-192
Application NumberANDA205575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Solifenacin Succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Solifenacin Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-193
Application NumberANDA205575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Solifenacin Succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (10)
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT