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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
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`Product Details for NDA 203415
`
`XTANDI (ENZALUTAMIDE)
`40MG
`
`Marketing Status: Prescription
`
`Active Ingredient: ENZALUTAMIDE
`Proprietary Name: XTANDI
`Dosage Form; Route of Administration: CAPSULE; ORAL
`Strength: 40MG
`Reference Listed Drug: Yes
`TE Code:
`
`Application Number: N203415
`Product Number: 001
`
`Approval Date: Aug 31, 2012
`Applicant Holder Full Name: ASTELLAS PHARMA US INC
`
`Marketing Status: Prescription
`Patent and Exclusivi
`Information
`
`http://www.accessdata.fda.gov/scripts/cder/oblresu|tsJ)roduct.cfm ?App|_Type=N&App|_N o=203415
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`JANSSEN EXHIBIT 2107
`Wockhardt v. Janssen IPR2016-01582
`
`