Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021518

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VESICARE (SOLIFENACIN SUCCINATE)
5MG Marketing Status: Prescription

Active Ingredient: SOLIFENACIN SUCCINATE
Proprietary Name: VESICARE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021518
Product Number: 001
Approval Date: Nov 19, 2004
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VESICARE (SOLIFENACIN SUCCINATE)
10MG Marketing Status: Prescription

Active Ingredient: SOLIFENACIN SUCCINATE
Proprietary Name: VESICARE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021518
Product Number: 002
Approval Date: Nov 19, 2004
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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