`
`
`
`
`
`A to Z Index
`
`Follow FDA
`
`En Español
`
`Home
`
`Food
`
`Drugs Medical Devices Radiation-Emitting Products
`
`Vaccines, Blood & Biologics
`
`Animal & Veterinary
`
`Cosmetics
`
`Tobacco Products
`
`FDA Home
`
`Drug Databases
`
`Drugs@FDA
`
`
`
`Drug Details
`
`Drug Name(s)
`
`FDA Application No.
`
`Active Ingredient(s)
`
`Company
`
`Original Approval or Tentative Approval Date
`
`Chemical Type
`
`Review Classification
`
`FAQ | Instructions | Glossary | Contact Us
`
`
`
`
`
`Email Link
`
`ZYTIGA
`
`(NDA) 202379
`
`ABIRATERONE ACETATE
`
`JANSSEN BIOTECH
`
`April 28, 2011
`
`1 New molecular entity (NME)
`
`P Priority review drug
`
`There are no Therapeutic Equivalents
`Approval History, Letters, Reviews, and Related Documents
`
`Label Information
`
`Products on Application (NDA) #202379
` Click on a column header to re-sort the table:
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`ZYTIGA
`
`ABIRATERONE ACETATE
`
`250MG
`
`TABLET;ORAL
`
`Marketing
`Status
`Prescription
`
`RLD
`
`Yes
`
`TE
`Code
`None
`
`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
`
`Disclaimer
`
`FDA/Center for Drug Evaluation and Research
`Office of Communications
`Division of Online Communications
`Update Frequency: Daily
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`
`Accessibility
`
`Contact FDA
`
`Careers
`
`FDA Basics
`
`FOIA
`
`No FEAR Act
`
`Site Map
`
`Transparency
`
`Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332
`Contact FDA
`
`)
`
`Combination Products
`
`Advisory Committees
`
`Science & Research
`
`Regulatory Information
`
`Safety
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails[6/28/2016 5:06:28 PM]
`
`MYLAN PHARMS. INC. EXHIBIT 1046 PAGE 1
`
`
`
`Drugs@FDA: FDA Approved Drug Products
`
`
`
`
`
`
`
`
`
`
`
`
`
`For Government
`
`For Press
`
`Emergency Preparedness
`
`International Programs
`
`News & Events
`
`Training and Continuing Education
`
`Inspections/Compliance
`
`State & Local Officials
`
`Consumers
`
`Industry
`
`Health Professionals
`
`FDA Archive
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails[6/28/2016 5:06:28 PM]
`
`MYLAN PHARMS. INC. EXHIBIT 1046 PAGE 2