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Generated: December 10, 2018

DrugPatentWatch Database Preview

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 one NDA. It is available from four suppliers. 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. Four 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:1
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 A-S Medication Solutions 50090-0972 50090-0972-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-0972-0)
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 19, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:May 19, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 19, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:May 19, 2019Product Flag?Substance Flag?Delist Request?Y

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