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SOLIFENACIN SUCCINATE

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

c84682ca-afca-a066-e053-2995a90a3257

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 3, 2021

Manufacturers
FDA

Golden State Medical Supply, Inc.

DUNS: 603184490

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 Code51407-471
Application NumberANDA211657
Product Classification
M
Marketing Category
C73584
G
Generic Name
SOLIFENACIN SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2021
FDA Product Classification

INGREDIENTS (8)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

SOLIFENACIN SUCCINATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51407-472
Application NumberANDA211657
Product Classification
M
Marketing Category
C73584
G
Generic Name
SOLIFENACIN SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2021
FDA Product Classification

INGREDIENTS (8)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB

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SOLIFENACIN SUCCINATE - FDA Drug Approval Details