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
dadb9462-953e-4319-b9f8-5b7255d1cf9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code71335-1729
Application NumberANDA210224
Product Classification
M
Marketing Category
C73584
G
Generic Name
Solifenacin Succinate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2020
FDA Product Classification
INGREDIENTS (10)
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT