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
d155c739-6870-4938-ba91-8c1b4b90afe4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
AustarPharma LLC
DUNS: 362785011
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 Code35561-286
Application NumberANDA210281
Product Classification
M
Marketing Category
C73584
G
Generic Name
solifenacin succinate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (1)
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
solifenacin succiate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-285
Application NumberANDA210281
Product Classification
M
Marketing Category
C73584
G
Generic Name
solifenacin succiate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (1)
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB