VESIcare
These highlights do not include all the information needed to use VESICARE safely and effectively. See full prescribing information for VESICARE. VESICARE (solifenacin succinate) tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
9acee910-cdb2-4052-b8b3-c26aff1c8716
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
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 Code51248-151
Application NumberNDA021518
Product Classification
M
Marketing Category
C73594
G
Generic Name
solifenacin succinate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (1)
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
solifenacin succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51248-150
Application NumberNDA021518
Product Classification
M
Marketing Category
C73594
G
Generic Name
solifenacin succinate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (1)
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB