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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 209529

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NDA 209529 describes VESICARE LS, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. Additional details are available on the VESICARE LS profile page.

The generic ingredient in VESICARE LS is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 209529
Tradename:VESICARE LS
Applicant:Astellas
Ingredient:solifenacin succinate
Patents:0
Pharmacology for NDA: 209529
Medical Subject Heading (MeSH) Categories for 209529
Suppliers and Packaging for NDA: 209529
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VESICARE LS solifenacin succinate SUSPENSION;ORAL 209529 NDA Astellas Pharma US, Inc. 51248-250 51248-250-99 1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) > 150 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength1MG/ML
Approval Date:May 26, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 26, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Nov 26, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Harvard Business School
Colorcon
McKesson
AstraZeneca

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