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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 021518


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NDA 021518 describes VESICARE, which is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VESICARE profile page.

The generic ingredient in VESICARE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 021518
Tradename:VESICARE
Applicant:Astellas
Ingredient:solifenacin succinate
Patents:0
Pharmacology for NDA: 021518
Medical Subject Heading (MeSH) Categories for 021518
Suppliers and Packaging for NDA: 021518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VESICARE solifenacin succinate TABLET;ORAL 021518 NDA Astellas Pharma US, Inc. 51248-150 51248-150-01 30 TABLET, FILM COATED in 1 BOTTLE (51248-150-01)
VESICARE solifenacin succinate TABLET;ORAL 021518 NDA Astellas Pharma US, Inc. 51248-151 51248-151-01 30 TABLET, FILM COATED in 1 BOTTLE (51248-151-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 19, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 19, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021518

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-001 Nov 19, 2004 ⤷  Sign Up ⤷  Sign Up
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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