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`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
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`Product Details for NDA 202611
`Expand all
`
`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
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&App...
`
`12/19/2017
`
`ASTELLAS 2002
`Sawai v. Astellas
`IPR2018-00079
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
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`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?Prod-
`uct_No=001&Appl_No=202611&Appl_type=N)
`
`MYRBETRIQ (MIRABEGRON)
`50MG
`
`Marketing Status: Prescription
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&App...
`
`12/19/2017
`
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