Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202611

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MYRBETRIQ (MIRABEGRON)
25MG Marketing Status: Prescription

Active Ingredient: MIRABEGRON
Proprietary Name: MYRBETRIQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202611
Product Number: 001
Approval Date: Jun 28, 2012
Applicant Holder Full Name: ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MYRBETRIQ (MIRABEGRON)
50MG Marketing Status: Prescription

Active Ingredient: MIRABEGRON
Proprietary Name: MYRBETRIQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202611
Product Number: 002
Approval Date: Jun 28, 2012
Applicant Holder Full Name: ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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