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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
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`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
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`Product Details for NBA 203971
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`XOFIGO (RADIUM RA-223 DICHLORIDE)
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`162mCi/6ML (27mCi/ML)
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`Marketing Status: Prescription
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`Active Ingredient: RADIUM RA-223 DICHLORIDE
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`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
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`Approval Date: May 15, 2013
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`Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
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`Marketing Status: Prescription
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`InformationPatent and Exclusivit atent info.cfm?
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`Product No=001&A INo=203971&A It
`e=N_
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`http://www.accessdata.fda.gov/scripts/cder/ob/resultSJJroductcfm ?AppI_Type=N&Appl_No=203971
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`JANSSEN EXHIBIT 2106
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`Wockhardt v. Janssen lPR2016-01582
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`JANSSEN EXHIBIT 2106
`Wockhardt v. Janssen IPR2016-01582
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