Details for New Drug Application (NDA): 021518

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-one 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

Mechanism of Action

Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for 021518

Muscarinic Antagonists

Urological Agents

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:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 19, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 19, 2004	TE:		RLD:	Yes

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