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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 203415
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`XTANDI (ENZALUTAMIDE)
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`40MG
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`Marketing Status: Prescription
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`Active Ingredient: ENZALUTAMIDE
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`Proprietary Name: XTANDI
`Dosage Form; Route of Administration: CAPSULE; ORAL
`Strength: 40MG
`Reference Listed Drug: Yes
`TE Code:
`
`Application Number: N203415
`Product Number: 001
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`Approval Date: Aug 31, 2012
`Applicant Holder Full Name: ASTELLAS PHARMA US 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 I No=203415&A I
`t
`=N_
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`http://www.accessdata.fda.gov/scripts/cder/ob/resultSJJroductcfm ?App|_Type=N&Appl_No=203415
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`JANSSEN EXHIBIT 2107
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`Wockhardt v. Janssen lPR2016-01582
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`JANSSEN EXHIBIT 2107
`Wockhardt v. Janssen IPR2016-01582
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`