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Drugs@FDA: FDA Approved Drug Products
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`ZYTIGA
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`(NDA) 202379
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`ABIRATERONE ACETATE
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`JANSSEN BIOTECH
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`April 28, 2011
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`1 New molecular entity (NME)
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`P Priority review drug
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`There are no Therapeutic Equivalents
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`Products on Application (NDA) #202379
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`ZYTIGA
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`ABIRATERONE ACETATE
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`250MG
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`TABLET;ORAL
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`Marketing
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`Prescription
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`RLD
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`Yes
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`TE
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`None
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`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails[6/28/2016 5:06:28 PM]
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`MYLAN PHARMS. INC. EXHIBIT 1046 PAGE 1
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`Drugs@FDA: FDA Approved Drug Products
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`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails[6/28/2016 5:06:28 PM]
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`MYLAN PHARMS. INC. EXHIBIT 1046 PAGE 2

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