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`U.S. Food and Drug Administration
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`Orange Book: Approved Drug Products
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`Product Details for NDA 203971
`
`XOFIGO (RADIUM RA-223 DICHLORIDE)
`162mCi/6ML (27mCi/ML)
`
`Marketing Status: Prescription
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`Active Ingredient: RADIUM RA-223 DICHLORIDE
`Proprietary Name: XOFIGO
`Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
`Strength: 162mCi/6ML (27mCi/ML)
`Reference Listed Drug: Yes
`TE Code:
`
`Application Number: N203971
`Product Number: 001
`
`Approval Date: May 15, 2013
`Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
`
`Marketing Status: Prescription
`Patent and Exclusivi
`Information
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`http://www.accessdata.fda.gov/scripts/cder/oblresu|tsJ)roduct.cfm ?App|_Type=N&App|_N o=203971
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`JANSSEN EXHIBIT 2106
`Wockhardt v. Janssen IPR2016-01582
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`