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
db6c24ae-e44b-456c-8e73-5961313ccf08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2022
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
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 Code69844-047
Application NumberANDA211423
Product Classification
M
Marketing Category
C73584
G
Generic Name
SOLIFENACIN SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2022
FDA Product Classification
INGREDIENTS (10)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SOLIFENACIN SUCCINATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-048
Application NumberANDA211423
Product Classification
M
Marketing Category
C73584
G
Generic Name
SOLIFENACIN SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2022
FDA Product Classification
INGREDIENTS (10)
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT