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9/24/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases4 Orange Book5
`
`Oran e Book: Approved Drug Products with Thera eutic Equivalence Evaluations
`Searc results from the "OB_Rx' table for query on "2 2379."
`
`Active Ingredient:
`
`Dosage Form;Route:
`
`Proprietary Name:
`
`Applicant:
`
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`ABIRATERONE ACETATE
`
`TABLET;ORAL
`
`ZYTIGA
`
`JANSSEN BIOTECH
`
`250MG
`
`N202379
`001
`
`Apr 28, 2011
`
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through August 2015
`Patent and Generic Drug Product Data Last Updated September 23, 2015
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2 3 4
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/defau|t.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`../defau|t.cfm
`
`../defau|t.cfm
`
`5 6
`
`.
`
`.
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading
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`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website
`Policies
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`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
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`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`T-"'2';-_"c_-+sIa::-'.... V
`
`E] I} E .".
`
`For Government For Press
`
`ARGEN UM EX1035
`ARGENTUM EX1035
`Page 1
`
`Combination Products Advisory Committees Science & Research Regulatory Information Safety
`Emergency Preparedness International Programs News & Events Training and Continuing
`Education Inspections/Compliance State & Local Officials Consumers Industry Health Professional:
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`http://www .accessdata.fda.gov/scri pts/cder/ob/docs/obdetai I .cfm ?Appl_N o= 202379&TABLE1 = OB_Rx
`
`1/2
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`Page 1
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`

`
`9/24/2015
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Archive
`
`£ US. Department -::If Health EL Human Services
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark. php?u508=true&v= 152&username=fda main
`
`2 3 4
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/defau|t.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`6 .
`
`../defau|t.cfm
`
`../defau|t.cfm
`
`http://www .accessdata.fda.gov/scri pts/cder/ob/docs/obdetai I .cfm ?App|_N o= 202379&TABLE1 = OB_Rx
`
`Page 2
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